The Effect of Roux-en-Y Gastric Bypass on Insulin Sensitivity in Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Anna Kirstine Bojsen-Moeller, Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT01202526
First received: September 15, 2010
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

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
Type 2 Diabetes
Obesity

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • Change in insulin sensitivity after RYGB [ Time Frame: 1 week, 3 months, 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in insulin secretion in response to oral glucose after RYGB [ Time Frame: 3 months, 1 year ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change in insulin secretion after iv glucose-glucagon after RYGB [ Time Frame: 1 week, 3months, 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

serum, plasma, urine, muscle, subcutaneous fat, visceral fat


Enrollment: 20
Study Start Date: September 2010
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01202526

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

No publications provided by Hvidovre University Hospital

Additional 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
Study First Received: September 15, 2010
Last Updated: October 24, 2013
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Hvidovre University Hospital:
Insulin resistance
Gastric bypass

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hyperinsulinism

ClinicalTrials.gov processed this record on July 24, 2014