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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
Information provided by (Responsible Party):

Study Description
Brief Summary:
Gastric bypass surgery induces remission of diabetes within days after surgery, before significant weight loss. The aim of the study is to examine whether improved insulin sensitivity of muscle and liver contributes to the immediate diabetes resolution.

Condition or disease
Type 2 Diabetes Obesity

Detailed Description:

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 Design

Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case Control
Time Perspective: Prospective
Study Start Date : September 2010
Primary Completion Date : March 2013
Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :
  1. Change in insulin sensitivity after RYGB [ Time Frame: 1 week, 3 months, 1 year ]

Secondary Outcome Measures :
  1. Change in insulin secretion in response to oral glucose after RYGB [ Time Frame: 3 months, 1 year ]

Other Outcome Measures:
  1. Change in insulin secretion after iv glucose-glucagon after RYGB [ Time Frame: 1 week, 3months, 1 year ]

Biospecimen Retention:   Samples Without DNA
serum, plasma, urine, muscle, subcutaneous fat, visceral fat

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects are recruited from the outpatient clinic of endocrinology and gastrosurgical clinic at Hvidovre University Hospital

Inclusion Criteria:

  • patients eligible for gastric bypass surgery
  • Verified type 2 diabetes or normal glucose tolerance by oral glucose tolerance test (OGTT)

Exclusion Criteria:

  • Treatment for Hyperthyroidism
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01202526

Hvidovre University Hospital
Copenhagen, Hvidovre, Denmark, DK-2650
Sponsors and Collaborators
Hvidovre University Hospital
University of Copenhagen
Principal Investigator: Anna Kirstine Bojsen-Møller, MD Hvidovre University Hospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anna Kirstine Bojsen-Moeller, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01202526     History of Changes
Other Study ID Numbers: ISBypass
First Posted: September 16, 2010    Key Record Dates
Last Update Posted: October 25, 2013
Last Verified: October 2013

Keywords provided by Anna Kirstine Bojsen-Moeller, Hvidovre University Hospital:
Insulin resistance
Gastric bypass

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases