- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01025999
Mechanisms of Glycemic Improvement After Gastrointestinal Surgery
March 29, 2016 updated by: David Flum, University of Washington
This study is designed as a prospective clinical trial aimed at investigating the mechanisms behind observed improvements in type 2 diabetes mellitus (T2DM) following bariatric surgery.
The majority of patients with T2DM who are undergoing Roux-en-Y gastric bypass (RYGB) surgery, in particular, experience complete remission of T2DM almost immediately post-surgery.
This response occurs before significant weight loss is possible.
To assess the mechanisms involved with disease resolution, the investigators propose a study to evaluate patients at the UW Medical Center (UWMC) who have T2DM and are undergoing RYGB with G (gastronomy)-tube placement as part of their clinical care.
The investigators are interested in this sub-population as the G-tube allows us the unique opportunity to evaluate glycemic control and insulin response following delivery or exclusion of nutrients to the otherwise bypassed portion of the gastrointestinal tract.
The investigators hypothesize that nutrient delivery to the proximal GI tract will reverse RYGB-mediated improvements in glucose homeostasis, possibly in association with changes in nutrient-regulated gut peptides involved in glucose control.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Roux-en-Y gastric bypass surgery causes complete, durable remission of type 2 diabetes (T2DM) in 84% of cases, typically within a few days to weeks after surgery.
Mounting evidence indicates that this dramatic phenomenon results from effects beyond those related to weight loss and reduced caloric intake alone.
The mechanisms mediating the weight-independent anti-diabetes impact of RYGB are unknown, and elucidating them could lead to new diabetes medicines.
Human subjects will undergo frequently sampled I.V. glucose tolerance tests (FS-IVGTT) and tracer-enhanced hyperinsulinemic/euglycemic clamps (to measure insulin secretion and sensitivity) before RYBG and 3 times in the first six weeks afterward, during which the proximal small bowel will either be excluded from nutrient contact or exposed to nutrients delivered through an indwelling gastric cannula.
We hypothesize that nutrient delivery to the proximal GI tract will reverse RYGB-mediated improvements in glucose homeostasis, possibly in association with changes in nutrient-regulated gut peptides involved in glucose control.
Our study will allow us to test the upper intestinal hypothesis rigorously in man, and whether the hypothesis is confirmed or refuted, we will gain valuable new insights into the mechanisms of improved glucose control early after RYGB.
Study Type
Observational
Enrollment (Actual)
7
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98195
- University of Washington Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients planning to undergo RYGB at UWMC with planned placement of gastrostomy tube.
Description
Inclusion Criteria:
- Age 18 years or greater and planning to undergo RYGB at UWMC
- Ability to speak English and communicate effectively with research staff
- Ability to return for follow-up visits at UWMC
- Adequate IV access
- A G-tube is planned as part of the bariatric surgical procedure
- Documented T2DM (fasting plasma glucose >125 mg/dL) that is treated with lifestyle efforts or by taking acceptable oral medications
Exclusion Criteria:
- Informed consent not obtained
- Unlikely to comply with the protocol
- Current HbA1c >8.5% or fasting blood glucose >180 mg/dL
- Serum creatinine >1.7 mg/dL
- Use of unacceptable diabetes medications at baseline
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
RYGB
UWMC patients undergoing RYGB surgery with routine placement of Gastrostomy tube.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine if the improvements in glycemic control occurring early after RYGB can be reversibly inactivated and activated through delivery or exclusion of nutrients in the bypassed proximal small intestine.
Time Frame: 1/2010 - 6/2014
|
1/2010 - 6/2014
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate whether improvements in glucose control occurring early after RYGB are related to altered insulin secretion, insulin sensitivity, or both.
Time Frame: 1/2010-6/2014
|
1/2010-6/2014
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: David R Flum, MD, MPH, University of Washington
- Principal Investigator: David E Cummings, MD, University of Washington
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
December 2, 2009
First Submitted That Met QC Criteria
December 3, 2009
First Posted (Estimate)
December 4, 2009
Study Record Updates
Last Update Posted (Estimate)
March 31, 2016
Last Update Submitted That Met QC Criteria
March 29, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 36417-A
- 1R01DK084324-01 (U.S. NIH Grant/Contract)
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.
Clinical Trials on Diabetes Mellitus, Type II
-
pico-tesla Magnetic Therapies, LLCCompletedType II Diabetes MellitusUnited States
-
Medical College of WisconsinMedical University of South CarolinaCompletedDiabetes Mellitus | Type 2 Diabetes Mellitus | Adult-Onset Diabetes Mellitus | Non-Insulin-Dependent Diabetes Mellitus | Noninsulin Dependent Diabetes Mellitus, Type IIUnited States
-
HealthInsightCenter for Technology and Aging; VoxivaUnknownType II Diabetes MellitusUnited States
-
KeyBioscience AGEli Lilly and Company; Profil Institut für Stoffwechselforschung GmbH; Nordic...TerminatedType II Diabetes MellitusGermany
-
University of PretoriaNestlè Nutrition Institute Africa; South African Sugar AssociationCompletedDiabetes Mellitus, Type II [Non-insulin Dependent Type] [NIDDM Type] UncontrolledSouth Africa
-
University of PrimorskaUniversity of Ljubljana School of Medicine, SloveniaCompletedDiabetes Mellitus Type II,Slovenia
-
Microbio Co LtdCompleted
-
Laboratorios Silanes S.A. de C.V.RecruitingDyslipidemia Associated With Type II Diabetes MellitusMexico
-
Assiut UniversityNot yet recruitingDyslipidemia Associated With Type II Diabetes Mellitus
Clinical Trials on No intervention
-
Wave NeuroscienceCompletedAutistic DisorderUnited States
-
University of Alabama at BirminghamCompletedInflammatory Bowel Diseases | Colorectal Cancer | Diverticular Diseases | Social BehaviorUnited States
-
Janssen Research & Development, LLCCompletedLupus Erythematosus, Systemic | Lupus Erythematosus, Cutaneous | Lupus Erythematosus, DiscoidUnited States, Poland
-
Hospital Universitario La Paz3MVX CCB and Agaplesion Markus Krankenhaus, Frankfurt a.M., Germany.; Department...RecruitingEmbolism | Atrial Fibrillation | Arrhythmia | Stroke, Acute | Stroke Sequelae | AblationSpain
-
Southern California College of Optometry at Marshall...Ohio State University; University of Houston; Alcon Research; University of Waterloo and other collaboratorsCompletedContact Lens Complication | Contact Lens Acute Red Eye | Contact Lens Related Corneal Infiltrate (Disorder) | Contact Lens-Induced Corneal Fluorescein StainingUnited States, Canada
-
University of Dublin, Trinity CollegeCompleted
-
Hôpital Necker-Enfants MaladesUnknown
-
China Medical University HospitalUnknownIntention to Stay, Turnover Behavior
-
University of PittsburghCompletedChronic Low Back PainUnited States