The Effect of Roux-en-Y Gastric Bypass on Insulin Sensitivity in Type 2 Diabetes
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|ClinicalTrials.gov Identifier: NCT01202526|
Recruitment Status : Completed
First Posted : September 16, 2010
Last Update Posted : October 25, 2013
|Condition or disease|
|Type 2 Diabetes Obesity|
Obesity has become a severe epidemic globally. With the rapid increase in obesity comes a pronounced rise in obesity-related disorders, especially type 2 diabetes. Weight loss achieved through lifestyle changes improves diabetes, but is very difficult to maintain over time. In contrast, Roux-en-Y gastric bypass (RYGB) surgery can induce long-term weight loss and remission of diabetes. Surprisingly, the resolution of type 2 diabetes occurs within days after surgery and before significant weight loss. The resolution of diabetes must therefore be explained by a response to the surgical alterations of the stomach and intestines: restriction in gastric volume and bypass of the stomach, duodenum and proximal jejunum.
Severe insulin resistance in muscle and liver is the common defect in obesity and type 2 diabetes and may be improved or even reversed shortly after the operation. The aim of this study is to examine the acute changes in insulin sensitivity of muscle and liver by using hyperinsulinaemic euglycaemic clamp combined with glucose tracer to assess hepatic glucose production. Insulin signaling pathways will be studied in biopsies from muscle and subcutaneous fat as to explain the molecular basis of the changes in insulin sensitivity after RYGB.
Insulin secretion will be evaluated in response to oral glucose as well as iv glucose-glucagon.
|Study Type :||Observational|
|Actual Enrollment :||20 participants|
|Observational Model:||Case Control|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
RYGB patients with type 2 diabetes
Morbid obese patients with type 2 diabetes undergoing gastric bypass surgery
RYGB patients without type 2 diabetes
Morbid obese patients with normal glucose tolerance undergoing gastric bypass surgery
- Change in insulin sensitivity after RYGB [ Time Frame: 1 week, 3 months, 1 year ]
- Change in insulin secretion in response to oral glucose after RYGB [ Time Frame: 3 months, 1 year ]
- Change in insulin secretion after iv glucose-glucagon after RYGB [ Time Frame: 1 week, 3months, 1 year ]
Biospecimen Retention: Samples Without DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01202526
|Hvidovre University Hospital|
|Copenhagen, Hvidovre, Denmark, DK-2650|
|Principal Investigator:||Anna Kirstine Bojsen-Møller, MD||Hvidovre University Hospital|