- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03038620
Impact of Liraglutide 3.0 on Body Fat Distribution
Impact of Liraglutide 3.0 on Body Fat Distribution, Visceral Adiposity, and Cardiometabolic Risk Markers In Overweight and Obese Adults at High Risk for Cardiovascular Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75390
- University of Texas Southwestern Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age ≥ 35 years
- Able to provide informed consent
- BMI ≥ 30 kg/m2 or ≥ 27 kg/m2 with metabolic syndrome
Metabolic syndrome is defined as at least three of the following:3
- waist circumference > 102 cm (40 in) in men and 88 cm (35 in) in women
- triglycerides > 150 mg/dL or on treatment for hypertriglyceridemia
- HDL cholesterol < 40 mg/dL in men and < 50 mg/dL in women
- blood pressure > 130/85 mmHg or on treatment for hypertension
- fasting glucose > 100 mg/dL
Exclusion Criteria:
- Treatment with Glucagon-like peptide-1 (GLP-1) receptor agonists (including liraglutide, exenatide or others as they become available), dipeptidyl peptidase 4 (DPP-4) inhibitors or insulin within the last 3 months.
- Receipt of any anti-obesity drug or supplement within 1 month prior to screening for this trial.
- Self-reported or clinically documented history of significant fluctuations (>5% change) in weight within 3 months prior to screening for this trial.
- History of diabetes mellitus (type 1 or 2) or on treatment with anti-diabetes medication.
- History of chronic pancreatitis or idiopathic acute pancreatitis (current or prior history).
- History of gallbladder disease (cholelithiasis or cholecystitis).
- Chronic kidney disease stage III or greater (eGFR<60 mL/min).
- Obesity induced by other endocrinologic disorders (e.g. Cushing Syndrome).
- Current or history of treatment with medications that may cause significant weight gain, within 1 month prior to screening for this trial, including systemic corticosteroids (except for a short course of treatment, i.e., 7- 10 days), tri-cyclic antidepressants, atypical antipsychotic and mood stabilizers (e.g., imipramine, amitryptiline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid and its derivatives, and lithium).
- Diet attempts using herbal supplements or over-the-counter medications within 1 month prior to screening for this trial.
- Current participation in an organized weight reduction program or within the last 1 month prior to screening for this trial.
- Participation in a clinical trial within the last 3 months prior to screening for this trial.
- Familial or personal history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma.
- Personal history of non-familial medullary thyroid carcinoma.
- History of Major Depressive Disorder within the last 2 years.
- History of other severe psychiatric disorders, e.g., schizophrenia, bipolar disorder.
- Any lifetime history of a suicide attempt.
- A history of any suicidal behavior in the last month prior to randomization.
- Surgery scheduled for the trial duration period, except for minor surgical procedures, at the discretion of the Investigator.
- Known or suspected hypersensitivity to trial product(s) or related product(s).
- Known or suspected abuse of alcohol or narcotics.
- Language barrier, mental incapacity, unwillingness or inability to understand.
- Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods. These include abstinence and the following methods: diaphragm with spermicide, condom with spermicide (by male partner), intrauterine device, sponge, spermicide, Norplant®, Depo-Provera® or oral contraceptives.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Liraglutide 3.0 mg
Drug: Liraglutide Active Drug Other Names:
Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. |
Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm.
Injections can be done at any time of day irrespective of meals.
Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.
Other Names:
|
Placebo Comparator: Placebo
Drug: Placebo (for Liraglutide at a concentration of 6.0 mg/mL) Placebo tablet manufactured to mimic Liraglutide at a concentration of 6.0 mg/mL Other Names:
Escalate the Placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection. |
Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm.
Injections can be done at any time of day irrespective of meals.
Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relative Percent Reduction in Visceral Adipose Tissue Mass Measured by MRI
Time Frame: Baseline, 40 weeks
|
The effect on relative percent reduction from baseline in visceral adipose tissue mass measured by MRI after 40 weeks on treatment. Positive numbers reflect the reduction in the value from baseline to study endpoint as a percent of the baseline. Reduction in this variable is believed to be associated with lower cardiovascular risk. |
Baseline, 40 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Absolute Reduction in Visceral Adipose Tissue Volume
Time Frame: Baseline, 40 weeks
|
The effect on absolute reduction from baseline in visceral adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint. Reduction in this variable is believed to be associated with lower cardiovascular risk. |
Baseline, 40 weeks
|
Relative Percent Reduction in Body Weight
Time Frame: Baseline, 40 weeks
|
The effect on relative percent reduction from baseline in body weight after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint. Reduction in this variable is believed to be associated with lower cardiovascular risk. |
Baseline, 40 weeks
|
Absolute Reduction in Body Weight
Time Frame: Baseline, 40 weeks
|
The effect on absolute reduction from baseline in body weight after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint. Reduction in this variable is believed to be associated with lower cardiovascular risk. |
Baseline, 40 weeks
|
Relative Percent Reduction in Waist Circumference
Time Frame: Baseline, 40 weeks
|
The effect on relative percent reduction from baseline in waist circumference after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint. Reduction in this variable is believed to be associated with lower cardiovascular risk. |
Baseline, 40 weeks
|
Absolute Reduction in Waist Circumference
Time Frame: Baseline, 40 weeks
|
The effect on absolute reduction from baseline in waist circumference after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint. Reduction in this variable is believed to be associated with lower cardiovascular risk. |
Baseline, 40 weeks
|
Relative Percent Reduction in Total Body Adipose Tissue
Time Frame: Baseline, 40 weeks
|
The effect on relative percent reduction from baseline in total body adipose tissue (fat) mass measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint. Reduction in this variable is believed to be associated with lower cardiovascular risk. |
Baseline, 40 weeks
|
Absolute Reduction in Total Body Adipose Tissue
Time Frame: Baseline, 40 weeks
|
The effect on absolute reduction from baseline in total body adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint. Reduction in this variable is believed to be associated with lower cardiovascular risk. |
Baseline, 40 weeks
|
Relative Percent Reduction in Abdominal Subcutaneous Adipose Tissue
Time Frame: Baseline, 40 weeks
|
The effect on relative percent reduction from baseline in abdominal subcutaneous adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint. |
Baseline, 40 weeks
|
Absolute Reduction in Abdominal Subcutaneous Adipose Tissue
Time Frame: Baseline, 40 weeks
|
The effect on absolute reduction from baseline in abdominal subcutaneous adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint. |
Baseline, 40 weeks
|
Relative Percent Reduction in Lower Body Subcutaneous Adipose Tissue
Time Frame: Baseline, 40 weeks
|
The effect on relative percent reduction from baseline in lower body subcutaneous adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint. |
Baseline, 40 weeks
|
Absolute Reduction in Lower Body Subcutaneous Adipose Tissue
Time Frame: Baseline, 40 weeks
|
The effect on absolute reduction from baseline in lower body subcutaneous adipose tissue mass measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint. |
Baseline, 40 weeks
|
Relative Percent Reduction in Liver Fat Percent
Time Frame: Baseline, 40 weeks
|
The effect on relative percent reduction from baseline in liver (hepatic) fat percentage measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint. Negative values reflect an increase in the value from baseline to study endpoint. Reduction in this variable is believed to be associated with lower cardiovascular risk. |
Baseline, 40 weeks
|
Absolute Reduction in Liver Fat Percent
Time Frame: Baseline, 40 weeks
|
The effect on absolute reduction from baseline in liver (hepatic) fat percentage measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint. Negative values reflect an increase in the value from baseline to study endpoint. Reduction in this variable is believed to be associated with lower cardiovascular risk. |
Baseline, 40 weeks
|
Relative Percent Reduction in Total Body Lean Volume
Time Frame: Baseline, 40 weeks
|
The effect on relative percent reduction from baseline in total body lean volume (fat-free mass) measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint. |
Baseline, 40 weeks
|
Absolute Reduction in Total Body Lean Volume
Time Frame: Baseline, 40 weeks
|
The effect on absolute reduction from baseline in total body lean volume (fat-free mass) measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint. |
Baseline, 40 weeks
|
Relative Percent Reduction in Total Thigh Muscle Volume
Time Frame: Baseline, 40 weeks
|
The effect on relative percent reduction from baseline in total thigh muscle volume measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint. |
Baseline, 40 weeks
|
Absolute Reduction in Total Thigh Muscle Volume
Time Frame: Baseline, 40 weeks
|
The effect on absolute reduction from baseline in total thigh muscle volume measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint. |
Baseline, 40 weeks
|
Relative Percent Reduction in Mean Anterior Thigh Muscle Fat Infiltration Percent
Time Frame: Baseline,40 weeks
|
The effect on relative percent reduction from baseline in mean anterior thigh muscle fat infiltration percent measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint. Negative values reflect an increase in the value from baseline to study endpoint. Reduction in this variable is believed to be associated with lower risk for metabolic disease. |
Baseline,40 weeks
|
Absolute Reduction in Mean Anterior Thigh Muscle Fat Infiltration Percent
Time Frame: Baseline,40 weeks
|
The effect on absolute reduction from baseline in mean anterior thigh muscle fat infiltration percent measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint. Negative values reflect an increase in the value from baseline to study endpoint. Reduction in this variable is believed to be associated with lower risk for metabolic disease |
Baseline,40 weeks
|
Change From Baseline in VAT/SAT Ratio
Time Frame: Baseline, 40 weeks
|
The effect on absolute reduction from baseline in Visceral adipose tissue/subcutaneous adipose tissue (VAT/SAT) ratio measured by MRI after 40 weeks on treatment versus placebo. Positive numbers reflect the reduction in the value from baseline to study endpoint. This is the ratio of visceral adipose tissue to subcutaneous adipose tissue and it is thought that lower values (relatively less visceral adipose tissue) are better. |
Baseline, 40 weeks
|
Change From Baseline in Total Fat/Fat-free Mass Ratio
Time Frame: Baseline, 40 weeks
|
The effect on absolute change from baseline in total fat/fat-free mass ratio measured by MRI after 40 weeks on treatment versus placebo. This is a ratio of fat to lean mass and it is believed that lower values (less fat relative to lean mass) is better. |
Baseline, 40 weeks
|
Relative Percent Change in Fasting Blood Glucose
Time Frame: Baseline, 40 weeks
|
The relative percent change in fasting blood glucose from baseline to study end point as a percent of baseline by treatment group. Negative values reflect a reduction. This is a blood based biomarker for diabetes in which normal levels are desirable (70-100 mg/dL). |
Baseline, 40 weeks
|
Relative Percent Change in Insulin
Time Frame: Baseline, 40 weeks
|
The relative percent change in insulin from baseline to study end point as a percent of baseline by treatment group. Positive values reflect an increase. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure. This is a blood based biomarker in which lower fasting levels are desirable. |
Baseline, 40 weeks
|
Relative Percent Change in HOMA-IR
Time Frame: Baseline, 40 weeks
|
The relative percent change in HOMA-IR from baseline to study end point as a percent of baseline by treatment group. Positive values reflect an increase. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure. The relative percent change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) from baseline to study end point by treatment group measures insulin resistance. Levels above 1.9 signal early insulin resistance, while levels above 2.9 signal significant insulin resistance. There will be optimal insulin sensitivity if HOMA-IR is less than 1. |
Baseline, 40 weeks
|
Relative Percent Change in C-reactive Protein
Time Frame: Baseline, 40 weeks
|
The relative percent change in biomarker of inflammation: C-reactive protein (CRP) from baseline to study end point as a percent of baseline by treatment group. Negative values reflect a decrease. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure. This is a blood based test for which lower values are associated with less inflammation and lower risk for cardiovascular events. |
Baseline, 40 weeks
|
Relative Percent Change in Triglyceride/HDL-C Ratio
Time Frame: Baseline, 40 weeks
|
The relative percent change in triglyceride/HDL-C ratio from baseline to study end point as a percent of baseline by treatment group. Negative values reflect a decrease. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure. Lower ratio of triglycerides to HDL-cholesterol is associated with less insulin resistance and lower cardiovascular risk. |
Baseline, 40 weeks
|
Relative Percent Change in Nt-proBNP
Time Frame: Baseline, 40 weeks
|
The relative percent change in N-terminal Pro Brain Natriuretic Peptides (Nt-proBNP) from baseline to study end point as a percent of baseline by treatment group. Negative values reflect a decrease. Collection was impacted by coronavirus disease 2019 (COVID-19) and limitations to in person study visits, limiting complete collection of data for this measure. NT-proBNP is a blood based biomarker. Lower levels are associated with lower risk for heart failure and cardiovascular events. |
Baseline, 40 weeks
|
Absolute Change in Fasting Blood Glucose
Time Frame: Baseline,40 weeks
|
The change in fasting blood glucose from baseline to study end point by treatment group.
|
Baseline,40 weeks
|
Absolute Change in Insulin
Time Frame: Baseline, 40 weeks
|
The absolute change in insulin from baseline to study end point by treatment group.
Collection was impacted by COVID-19 and changes to study visits.
|
Baseline, 40 weeks
|
Absolute Change in HOMA-IR
Time Frame: Baseline, 40 weeks
|
The absolute change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) from baseline to study end point by treatment group measures insulin resistance.
Levels above 1.9 signal early insulin resistance, while levels above 2.9 signal significant insulin resistance.
There will be optimal insulin sensitivity if HOMA-IR is less than 1.
Collection was impacted by COVID-19 and changes to study visits.
|
Baseline, 40 weeks
|
Absolute Change in CRP
Time Frame: Baseline, 40 weeks
|
The change in Markers of inflammation: C-reactive protein (CRP) from baseline to study end point by treatment group. Collection was impacted by COVID-19 and changes to study visits. This is a blood based test for which lower values are associated with less inflammation and lower risk for cardiovascular events. |
Baseline, 40 weeks
|
Absolute Change in Triglyceride/HDL-C Ratio
Time Frame: Baseline, 40 weeks
|
The change in triglyceride/HDL-C ratio from baseline to study end point by treatment group. Collection was impacted by COVID-19 and changes to study visits. Lower ratio of triglycerides to HDL-cholesterol is associated with less insulin resistance and lower cardiovascular risk. |
Baseline, 40 weeks
|
Absolute Change in Nt-proBNP
Time Frame: Baseline, 40 weeks
|
The change in N-terminal Pro Brain Natriuretic Peptides (Nt-proBNP) from baseline to study end point by treatment group. Collection was impacted by COVID-19 and changes to study visits. NT-proBNP is a blood based biomarker. Lower levels are associated with lower risk for heart failure and cardiovascular events. |
Baseline, 40 weeks
|
Change From Baseline in Heart Rate
Time Frame: Baseline, 40 weeks
|
The change in heart rate/pulse from baseline to study endpoint visit by treatment group.
|
Baseline, 40 weeks
|
Change From Baseline in Blood Pressure
Time Frame: Baseline, 40 weeks
|
The change in systolic blood pressure from baseline to study endpoint visit by treatment group.
|
Baseline, 40 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
On-treatment Time, Weeks
Time Frame: weeks
|
The mean duration of treatment during study follow-up.
|
weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Parag Joshi, MD, University of Texas Southwestern Medical Center
Publications and helpful links
General Publications
- Berrington de Gonzalez A, Hartge P, Cerhan JR, Flint AJ, Hannan L, MacInnis RJ, Moore SC, Tobias GS, Anton-Culver H, Freeman LB, Beeson WL, Clipp SL, English DR, Folsom AR, Freedman DM, Giles G, Hakansson N, Henderson KD, Hoffman-Bolton J, Hoppin JA, Koenig KL, Lee IM, Linet MS, Park Y, Pocobelli G, Schatzkin A, Sesso HD, Weiderpass E, Willcox BJ, Wolk A, Zeleniuch-Jacquotte A, Willett WC, Thun MJ. Body-mass index and mortality among 1.46 million white adults. N Engl J Med. 2010 Dec 2;363(23):2211-9. doi: 10.1056/NEJMoa1000367. Erratum In: N Engl J Med. 2011 Sep 1;365(9):869.
- Alberti KG, Zimmet P, Shaw J; IDF Epidemiology Task Force Consensus Group. The metabolic syndrome--a new worldwide definition. Lancet. 2005 Sep 24-30;366(9491):1059-62. doi: 10.1016/S0140-6736(05)67402-8. No abstract available.
- Astrup A, Rossner S, Van Gaal L, Rissanen A, Niskanen L, Al Hakim M, Madsen J, Rasmussen MF, Lean ME; NN8022-1807 Study Group. Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study. Lancet. 2009 Nov 7;374(9701):1606-16. doi: 10.1016/S0140-6736(09)61375-1. Epub 2009 Oct 23. Erratum In: Lancet. 2010 Mar 20;375(9719):984.
- Astrup A, Carraro R, Finer N, Harper A, Kunesova M, Lean ME, Niskanen L, Rasmussen MF, Rissanen A, Rossner S, Savolainen MJ, Van Gaal L; NN8022-1807 Investigators. Safety, tolerability and sustained weight loss over 2 years with the once-daily human GLP-1 analog, liraglutide. Int J Obes (Lond). 2012 Jun;36(6):843-54. doi: 10.1038/ijo.2011.158. Epub 2011 Aug 16. Erratum In: Int J Obes (Lond). 2012 Jun;36(6):890. Int J Obes (Lond). 2013 Feb;37(2):322.
- Grundy SM, Cleeman JI, Daniels SR, Donato KA, Eckel RH, Franklin BA, Gordon DJ, Krauss RM, Savage PJ, Smith SC Jr, Spertus JA, Fernando Costa. Diagnosis and management of the metabolic syndrome: an American Heart Association/National Heart, Lung, and Blood Institute scientific statement: Executive Summary. Crit Pathw Cardiol. 2005 Dec;4(4):198-203. doi: 10.1097/00132577-200512000-00018. No abstract available.
- Despres JP. Body fat distribution and risk of cardiovascular disease: an update. Circulation. 2012 Sep 4;126(10):1301-13. doi: 10.1161/CIRCULATIONAHA.111.067264. No abstract available.
- Garvey WT, Garber AJ, Mechanick JI, Bray GA, Dagogo-Jack S, Einhorn D, Grunberger G, Handelsman Y, Hennekens CH, Hurley DL, McGill J, Palumbo P, Umpierrez G; The Aace Obesity Scientific Committee. American association of clinical endocrinologists and american college of endocrinology position statement on the 2014 advanced framework for a new diagnosis of obesity as a chronic disease. Endocr Pract. 2014 Sep;20(9):977-89. doi: 10.4158/EP14280.PS. No abstract available.
- Morkedal B, Vatten LJ, Romundstad PR, Laugsand LE, Janszky I. Risk of myocardial infarction and heart failure among metabolically healthy but obese individuals: HUNT (Nord-Trondelag Health Study), Norway. J Am Coll Cardiol. 2014 Mar 25;63(11):1071-8. doi: 10.1016/j.jacc.2013.11.035. Epub 2013 Dec 15.
- Despres JP, Lemieux I, Bergeron J, Pibarot P, Mathieu P, Larose E, Rodes-Cabau J, Bertrand OF, Poirier P. Abdominal obesity and the metabolic syndrome: contribution to global cardiometabolic risk. Arterioscler Thromb Vasc Biol. 2008 Jun;28(6):1039-49. doi: 10.1161/ATVBAHA.107.159228. Epub 2008 Mar 20. Erratum In: Arterioscler Thromb Vasc Biol. 2008 Jul;28(7):e151.
- McLaughlin T, Lamendola C, Liu A, Abbasi F. Preferential fat deposition in subcutaneous versus visceral depots is associated with insulin sensitivity. J Clin Endocrinol Metab. 2011 Nov;96(11):E1756-60. doi: 10.1210/jc.2011-0615. Epub 2011 Aug 24.
- McLaughlin T, Sherman A, Tsao P, Gonzalez O, Yee G, Lamendola C, Reaven GM, Cushman SW. Enhanced proportion of small adipose cells in insulin-resistant vs insulin-sensitive obese individuals implicates impaired adipogenesis. Diabetologia. 2007 Aug;50(8):1707-15. doi: 10.1007/s00125-007-0708-y. Epub 2007 Jun 5.
- See R, Abdullah SM, McGuire DK, Khera A, Patel MJ, Lindsey JB, Grundy SM, de Lemos JA. The association of differing measures of overweight and obesity with prevalent atherosclerosis: the Dallas Heart Study. J Am Coll Cardiol. 2007 Aug 21;50(8):752-9. doi: 10.1016/j.jacc.2007.04.066. Epub 2007 Aug 6.
- Cerhan JR, Moore SC, Jacobs EJ, Kitahara CM, Rosenberg PS, Adami HO, Ebbert JO, English DR, Gapstur SM, Giles GG, Horn-Ross PL, Park Y, Patel AV, Robien K, Weiderpass E, Willett WC, Wolk A, Zeleniuch-Jacquotte A, Hartge P, Bernstein L, Berrington de Gonzalez A. A pooled analysis of waist circumference and mortality in 650,000 adults. Mayo Clin Proc. 2014 Mar;89(3):335-45. doi: 10.1016/j.mayocp.2013.11.011.
- Hsu WC, Araneta MR, Kanaya AM, Chiang JL, Fujimoto W. BMI cut points to identify at-risk Asian Americans for type 2 diabetes screening. Diabetes Care. 2015 Jan;38(1):150-8. doi: 10.2337/dc14-2391. No abstract available.
- Neeland IJ, Ayers CR, Rohatgi AK, Turer AT, Berry JD, Das SR, Vega GL, Khera A, McGuire DK, Grundy SM, de Lemos JA. Associations of visceral and abdominal subcutaneous adipose tissue with markers of cardiac and metabolic risk in obese adults. Obesity (Silver Spring). 2013 Sep;21(9):E439-47. doi: 10.1002/oby.20135. Epub 2013 May 19.
- Neeland IJ, Turer AT, Ayers CR, Powell-Wiley TM, Vega GL, Farzaneh-Far R, Grundy SM, Khera A, McGuire DK, de Lemos JA. Dysfunctional adiposity and the risk of prediabetes and type 2 diabetes in obese adults. JAMA. 2012 Sep 19;308(11):1150-9. doi: 10.1001/2012.jama.11132.
- Chandra A, Neeland IJ, Berry JD, Ayers CR, Rohatgi A, Das SR, Khera A, McGuire DK, de Lemos JA, Turer AT. The relationship of body mass and fat distribution with incident hypertension: observations from the Dallas Heart Study. J Am Coll Cardiol. 2014 Sep 9;64(10):997-1002. doi: 10.1016/j.jacc.2014.05.057.
- Neeland IJ, Gupta S, Ayers CR, Turer AT, Rame JE, Das SR, Berry JD, Khera A, McGuire DK, Vega GL, Grundy SM, de Lemos JA, Drazner MH. Relation of regional fat distribution to left ventricular structure and function. Circ Cardiovasc Imaging. 2013 Sep;6(5):800-7. doi: 10.1161/CIRCIMAGING.113.000532. Epub 2013 Aug 8.
- Britton KA, Massaro JM, Murabito JM, Kreger BE, Hoffmann U, Fox CS. Body fat distribution, incident cardiovascular disease, cancer, and all-cause mortality. J Am Coll Cardiol. 2013 Sep 3;62(10):921-5. doi: 10.1016/j.jacc.2013.06.027. Epub 2013 Jul 10.
- Wadden TA, Hollander P, Klein S, Niswender K, Woo V, Hale PM, Aronne L; NN8022-1923 Investigators. Weight maintenance and additional weight loss with liraglutide after low-calorie-diet-induced weight loss: the SCALE Maintenance randomized study. Int J Obes (Lond). 2013 Nov;37(11):1443-51. doi: 10.1038/ijo.2013.120. Epub 2013 Jul 1. Erratum In: Int J Obes (Lond). 2013 Nov;37(11):1514. Int J Obes (Lond). 2015 Jan;39(1):187.
- Borga M, Thomas EL, Romu T, Rosander J, Fitzpatrick J, Dahlqvist Leinhard O, Bell JD. Validation of a fast method for quantification of intra-abdominal and subcutaneous adipose tissue for large-scale human studies. NMR Biomed. 2015 Dec;28(12):1747-53. doi: 10.1002/nbm.3432. Epub 2015 Nov 2.
- Schaudinn A, Linder N, Garnov N, Kerlikowsky F, Bluher M, Dietrich A, Schutz T, Karlas T, Kahn T, Busse H. Predictive accuracy of single- and multi-slice MRI for the estimation of total visceral adipose tissue in overweight to severely obese patients. NMR Biomed. 2015 May;28(5):583-90. doi: 10.1002/nbm.3286. Epub 2015 Mar 25.
- Dong Z, Luo Y, Zhang Z, Cai H, Li Y, Chan T, Wu L, Li ZP, Feng ST. MR quantification of total liver fat in patients with impaired glucose tolerance and healthy subjects. PLoS One. 2014 Oct 24;9(10):e111283. doi: 10.1371/journal.pone.0111283. eCollection 2014.
- Thomas MS, Newman D, Leinhard OD, Kasmai B, Greenwood R, Malcolm PN, Karlsson A, Rosander J, Borga M, Toms AP. Test-retest reliability of automated whole body and compartmental muscle volume measurements on a wide bore 3T MR system. Eur Radiol. 2014 Sep;24(9):2279-91. doi: 10.1007/s00330-014-3226-6. Epub 2014 May 29.
- Human energy requirements: report of a joint FAO/ WHO/UNU Expert Consultation. Food Nutr Bull. 2005 Mar;26(1):166. No abstract available.
- Neeland IJ, Marso SP, Ayers CR, Lewis B, Oslica R, Francis W, Rodder S, Pandey A, Joshi PH. Effects of liraglutide on visceral and ectopic fat in adults with overweight and obesity at high cardiovascular risk: a randomised, double-blind, placebo-controlled, clinical trial. Lancet Diabetes Endocrinol. 2021 Sep;9(9):595-605. doi: 10.1016/S2213-8587(21)00179-0. Epub 2021 Aug 3.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU 122015-044
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Oregon Health and Science UniversityCompletedCardiovascular Disease | Cardiovascular Risk FactorsUnited States
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Women's College HospitalUniversity Health Network, Toronto; Sunnybrook Health Sciences Centre; Brigham... and other collaboratorsUnknownCARDIOVASCULAR DISEASESCanada, United States
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Groupe Hospitalier Paris Saint JosephTerminatedCARDIOVASCULAR DISEASESFrance
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University of FloridaUniversity of Alabama at Birmingham; Brown UniversityCompletedCardiovascular Disease | Psychosocial Influence on Cardiovascular DiseaseUnited States
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VA Office of Research and DevelopmentNot yet recruitingCardiovascular DiseaseUnited States
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Baptist Health South FloridaUniversity of California, Los Angeles; Quest Diagnostics-Nichols InsituteActive, not recruitingCardiovascular DiseaseUnited States
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Laval UniversityActive, not recruitingCardiovascular DiseaseCanada
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Penn State UniversityCalifornia Healthcare InstituteCompleted
Clinical Trials on Liraglutide
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Woman'sNovo Nordisk A/SCompletedPolycystic Ovary Syndrome | Pre Diabetes | Obesity AndroidUnited States
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Novo Nordisk A/SCompleted
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The Affiliated Hospital of Qingdao UniversityCompletedTherapeutic EquivalencyChina
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Sunshine Lake Pharma Co., Ltd.Completed
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Merck Sharp & Dohme LLCCompleted
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Henrik GudbergsenCompletedObesity | OsteoarthritisDenmark
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Parker Research InstituteCompletedOsteoarthritis, KneeDenmark
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Henrik GudbergsenNovo Nordisk A/S; Cambridge Weight Plan LimitedCompleted
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Henrik GudbergsenCompletedUltrasound of the Knee in Obese Patients With Knee Osteoarthritis; Weight Maintenance (US-LOSEIT-II)Obesity | OsteoarthritisDenmark
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Henrik GudbergsenCompletedObesity | OsteoarthritisDenmark