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

NCT ID: NCT01202526

Last Updated: 2013-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-03-31

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes Obesity

Keywords

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Insulin resistance Gastric bypass

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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RYGB patients with type 2 diabetes

Morbid obese patients with type 2 diabetes undergoing gastric bypass surgery

No interventions assigned to this group

RYGB patients without type 2 diabetes

Morbid obese patients with normal glucose tolerance undergoing gastric bypass surgery

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Copenhagen

OTHER

Sponsor Role collaborator

Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Anna Kirstine Bojsen-Moeller

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anna Kirstine Bojsen-Møller, MD

Role: PRINCIPAL_INVESTIGATOR

Hvidovre University Hospital

Locations

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Hvidovre University Hospital

Copenhagen, Hvidovre, Denmark

Site Status

Countries

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Denmark

References

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Wewer Albrechtsen NJ, Hartmann B, Veedfald S, Windelov JA, Plamboeck A, Bojsen-Moller KN, Idorn T, Feldt-Rasmussen B, Knop FK, Vilsboll T, Madsbad S, Deacon CF, Holst JJ. Hyperglucagonaemia analysed by glucagon sandwich ELISA: nonspecific interference or truly elevated levels? Diabetologia. 2014 Sep;57(9):1919-26. doi: 10.1007/s00125-014-3283-z. Epub 2014 Jun 3.

Reference Type DERIVED
PMID: 24891019 (View on PubMed)

Bojsen-Moller KN, Dirksen C, Jorgensen NB, Jacobsen SH, Serup AK, Albers PH, Hansen DL, Worm D, Naver L, Kristiansen VB, Wojtaszewski JF, Kiens B, Holst JJ, Richter EA, Madsbad S. Early enhancements of hepatic and later of peripheral insulin sensitivity combined with increased postprandial insulin secretion contribute to improved glycemic control after Roux-en-Y gastric bypass. Diabetes. 2014 May;63(5):1725-37. doi: 10.2337/db13-1307. Epub 2013 Nov 15.

Reference Type DERIVED
PMID: 24241533 (View on PubMed)

Other Identifiers

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ISBypass

Identifier Type: -

Identifier Source: org_study_id