Effects of Caloric Restriction Alone Versus Postoperative Caloric Restriction Following Bariatric Surgery on Glucose Metabolism in Patients With Diabetes Mellitus
|First Received Date ICMJE||March 6, 2010|
|Last Updated Date||May 9, 2014|
|Start Date ICMJE||February 2010|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||The primary outcome of the study is the change in total body insulin sensitivity due to Roux-en-Y Gastric By pass surgery alone using the euglycemic hyperinsulinemic clamp technique. [ Time Frame: 2 years ] [ Designated as safety issue: No ]|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01083108 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||To determine possible mechanisms underlying resolution of diabetes after bariatric surgery. To explore this, in addition to assessing total body insulin sensitivity, we will evaluate hepatic insulin sensitivity, insulin secretion and gut hormone... [ Time Frame: 2 years ] [ Designated as safety issue: No ]|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Effects of Caloric Restriction Alone Versus Postoperative Caloric Restriction Following Bariatric Surgery on Glucose Metabolism in Patients With Diabetes Mellitus|
|Official Title ICMJE||Effects of Caloric Restriction Alone Versus Postoperative Caloric Restriction Following Bariatric Surgery on Glucose Metabolism in Patients With Diabetes Mellitus|
- Individuals 18 to 60 years of age who have a body mass index (BMI) greater than 35 and have type 2 diabetes.
- This is not a randomized study, and patients will not receive bariatric surgery as part of this study.
Two groups of patients will be studied: those scheduled for RYGBP surgery and those not undergoing surgery.
Presently it is unknown whether the rapid normalization of glucose metabolism in obese patients with type 2 diabetes after bariatric surgery (before major weight loss occurs) is primarily due to acute postoperative caloric restriction or due to changes in intestinal effects on insulin secretion and sensitivity. We speculate that bypassing the stomach and proximal small intestine affects glucose metabolism beyond simple caloric restriction, and that the mechanisms are related to changes in hepatic and muscle insulin sensitivity, changes in vagal afferent signals, and changes in incretins and other gut hormones.
To compare the effects of pure caloric restriction with caloric restriction early after bariatric surgery (Roux-en-Y Gastric Bypass, RYGBP) in patients with type 2 diabetes, and to investigate the mechanisms that explain the observed difference in glucose metabolism
In patients with type 2 diabetes we will study the short-term changes in glucose metabolism, insulin sensitivity and gut hormone levels using a parallel group design. The non-surgical group will be studied before and after receiving a hypocaloric diet for 6 days mimicking the typical postoperative diet. The surgical group will be studied before and 6 days after bariatric surgery. The primary outcome will be the change in total body insulin sensitivity attributable to caloric restriction alone versus caloric restriction after RYGBP. Non-surgical subjects studied at NIH may enter an optional long-term weight loss phase.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Study Arm (s)||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||May 2013|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 60 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT01083108|
|Other Study ID Numbers ICMJE||100064, 10-DK-0064|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )|
|Study Sponsor ICMJE||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||April 2014|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP