- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02994459
Study of Fat Tissue's Ability to Take up Sugar in the Obese Population (ATGD)
Adipose Tissue Glucose Uptake in Obesity (ATGD)
People who are obese often have insulin resistance (inability of insulin to properly control blood sugar) and high blood sugar. However, not all people with obesity have this problem. About one-third of people with obesity have normal sugar metabolism (the way your body uses sugar). Similarly, not all people who are lean are also metabolically healthy and a subset of people who are lean are referred to as metabolically abnormal lean (MAL) or metabolically obese lean because they have the abnormalities in glucose metabolism typically associated with obesity. The reasons why some people with obesity have a problem with blood sugar control and others do not are not entirely clear. It is thought that impaired muscle sugar uptake is the main problem related to high blood sugar in people with obesity. However, adipose tissue (fat tissue) also consumes a substantial amount of blood sugar. Therefore, it is unclear whether muscle or adipose tissue (fat tissue) are primarily responsible for altered blood sugar concentrations in persons with metabolically abnormal obesity (MAO) (those with insulin resistance), compared to those with metabolically normal (healthy) obesity (MNO), or whether "healthy" adipose tissue (fat tissue) expansion in MNO people compared with lean people provides a vessel for blood sugar removal that helps maintain normal blood sugar concentration.
Accordingly, the investigators will determine the amount of sugar that is taken up by the body and in the cells of adipose tissue (fat tissue) and muscle by infusing labeled sugar into the blood and looking at its disappearance from blood and appearance in adipose tissue (fat tissue) and muscle. The investigators will also determine how well insulin, a hormone that controls blood sugar, turns on signals that stimulate sugar uptake in fat and muscle cells. These studies will be done after an overnight fast and during an infusion of sugar and insulin (hyperinsulinemic-euglycemic clamp), in sex- and age-matched people who are insulin resistant and insulin sensitive. People with obesity will also be invited to complete a ~10% diet-induced weight loss program and will be studied again after they have achieved the weight loss goal. A group of sex- and age-matched metabolically normal lean participants will serve as control group. An attempt will be made to also study a group of sex- and age-matched metabolically abnormal lean participants.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
All subjects
- Age: greater than or equal to 18 years but <65 years
- Weight stable (i.e., ±2 kg for at least 3 months)
- Sedentary (less than 1 hour of structured exercise per week)
- No evidence of significant organ system dysfunction or disease (e.g., diabetes, impaired kidney function, cancer, etc.)
In addition, subjects must fulfill all of the following inclusion criteria.
Metabolically Normal Lean
- BMI greater than or equal to 18.5 but <25.0 kg/m2
- Fasting blood glucose: <100 mg/dl
- Blood glucose 2 h after an OGTT: <140 mg/dl
- HbA1c <5.7 %.
Metabolically Normal Obese, likely insulin sensitive
- BMI greater than or equal to 30.0 but <45.0 kg/m2
- Fasting blood glucose: <100 mg/dl
- Fasting insulin: <20 mU/l
- Blood glucose 2 h after an OGTT: <140 mg/dl
- HbA1c <5.7 %.
Metabolically Abnormal Obese, likely insulin resistant
- BMI greater than or equal to 30.0 but <45.0 kg/m2
- Fasting blood glucose ≥100 mg/dl or blood glucose 2 h after an OGTT ≥140 mg/dl or fasting insulin >20 µU/mL or HbA1c >5.7 %.
Metabolically Abnormal Lean
- BMI greater than or equal to 18.5 but <25.0 kg/m2
- Fasting blood glucose ≥100 mg/dl or blood glucose 2 h after an OGTT ≥140 mg/dl or fasting insulin >20 µU/mL or HbA1c >5.7 %.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Metabolically Normal Obese (likely insulin sensitive)
i) BMI ≥30.0 but <45.0 kg/m2; maximum body circumference <165 cm to ensure subjects fit into the PET/CT and MR scanners; iii) fasting blood glucose: <100 mg/dl; iv) blood glucose 2 h after an OGTT: <140 mg/dl; v) HbA1c <5.7 %; vi) fasting insulin: <20 µU/mL.
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Diet-induced weight loss (obese only)
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Metabolically Abnormal Obese (likely insulin resistant)
i) BMI ≥30.0 but <45.0 kg/m2; maximum body circumference <165 cm to ensure subjects fit into the PET/CT and MR scanners; iii) fasting blood glucose: ≥100 mg/dl or blood glucose 2 h after an OGTT: ≥140 or fasting insulin: >20 µU/mL.
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Diet-induced weight loss (obese only)
|
Metabolically Normal Lean
i) BMI ≥18.5 but <25.0 kg/m2; ii) maximum body circumference <165 cm to ensure subjects fit into the PET/CT and MR scanners; iii) fasting blood glucose: <100 mg/dl; iv) blood glucose 2 h after an OGTT: <140 mg/dl; v) HbA1c <5.7 %; vi) fasting insulin: <20 µU/mL.
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Metabolically Abnormal Lean
i) BMI ≥18.5 but <25.0 kg/m2; ii) maximum body circumference <165 cm to ensure subjects fit into the PET/CT and MR scanners; iii) iii) fasting blood glucose: ≥100 mg/dl or blood glucose 2 h after an OGTT: ≥140 or fasting insulin: >20 µU/mL.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Contribution of subcutaneous adipose tissue glucose uptake to whole-body glucose disposal in people who are insulin sensitive or insulin resistant (defined as insulin-mediated glucose disposal rate)
Time Frame: Baseline
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Comparison of whole body and total adipose tissue glucose disposal rate assessed by using stable isotope labeled glucose tracer infusion in conjunction with dynamic PET imaging
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Baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bettina Mittendorfer, PhD, Washington University School of Medicine
Publications and helpful links
General Publications
- Cao C, Koh HE, Van Vliet S, Patterson BW, Reeds DN, Laforest R, Gropler RJ, Mittendorfer B. Increased plasma fatty acid clearance, not fatty acid concentration, is associated with muscle insulin resistance in people with obesity. Metabolism. 2022 Jul;132:155216. doi: 10.1016/j.metabol.2022.155216. Epub 2022 May 13.
- van Vliet S, Koh HE, Patterson BW, Yoshino M, LaForest R, Gropler RJ, Klein S, Mittendorfer B. Obesity Is Associated With Increased Basal and Postprandial beta-Cell Insulin Secretion Even in the Absence of Insulin Resistance. Diabetes. 2020 Oct;69(10):2112-2119. doi: 10.2337/db20-0377. Epub 2020 Jul 10.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201610005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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