Intestinal Metabolic Reprogramming as a Key Mechanism of Gastric Bypass in Humans
Running, not enrolling
Conditions studied: Obesity, Diabetes Mellitus, Type 2, Endocrine System Diseases, Glucose Metabolism Disorders, Metabolic Diseases
In brief
The purpose of this research study is to determine how gastric bypass surgery effects metabolism in obesity and Type 2 Diabetes. One mechanism that has been investigated in animal models is change to the biology of the small intestine (Roux limb) and how glucose and other fuels are metabolized (or how the body digests and uses sugar and other fuels). This study will evaluate the role of the intestine in the beneficial metabolic effects of gastric bypass surgery. It specifically will examine whether the intestine increases its metabolism and its activity, and whether this results in an increase in fuel utilization. Thirty two (32) subjects will be recruited (18 with and 14 without Type 2 Diabetes). At the time of gastric bypass surgery, a small piece of intestine that is usually discarded will be collected. At three time points over the first year after surgery, intestinal samples will be obtained by endoscopy or insertion of a lighted flexible tube through the mouth. Blood samples will be taken at all time points, as well. All samples will undergo comprehensive metabolic analyses. Comparisons will be made between the two groups to understand the metabolic changes over time and if there are differences between the two groups.
Key facts
- Study ID
- NCT02710370
- Run by
- University of Pittsburgh
- People needed
- 46
- Starts
- 2016-02-01
- Expected to finish
- 2028-08-31
- Last updated by the study team
- 2026-06-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients who elect to undergo gastric bypass surgery
- Standard bariatric surgery criteria (A BMI 35 to 40 kg/m2, with an obesity comorbid condition, OR BMI 40 kg/m2 or >).
You may not qualify if…
- Prior bariatric or foregut surgery
- Documented history of Type 1 Diabetes
- Poor overall general health
- Impaired mental status
- Drug and/or alcohol addiction
- Currently smoking
- Pregnant or plans to become pregnant
- Portal hypertension and/or cirrhosis
Where it is running
- Magee-Womens Hospital of UPMC — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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