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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01202526
Enrollment
20
Registered
2010-09-16
Start date
2010-09-30
Completion date
2013-03-31
Last updated
2013-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Type 2 Diabetes

Keywords

Insulin resistance, Gastric bypass

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.

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.

Interventions

None listed

Sponsors

University of Copenhagen
CollaboratorOTHER
Hvidovre University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Change in insulin sensitivity after RYGB1 week, 3 months, 1 year

Secondary

MeasureTime frame
Change in insulin secretion in response to oral glucose after RYGB3 months, 1 year

Other

MeasureTime frame
Change in insulin secretion after iv glucose-glucagon after RYGB1 week, 3months, 1 year

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026