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Effect of RYGB on Alpha- and Beta Cell Function and Sensitivity to Incretins in Patients With Type 2 Diabetes

NCT04782999 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2022-03-16

No results posted yet for this study

Summary

The aim of the study is to investigate the effect of Roux-en-Y gastric bypass (RYGB) on pancreatic alpha and beta-cell function and for the sensitivity of incretin hormones in patients with pre-operative type 2 diabetes.

Primary hypotheses:

* After RYGB, the sensitivity to GLP-1 and GIP is improved (improved insulinotropic effect).
* After RYGB, the insulin secretion improves during an oral glucose tolerance test within 3 months postoperatively.
* After RYGB, the insulin secretion during intraveneous stimulation with glucose or non-glucose (arginin) is unchanged.

Conditions

  • Type2 Diabetes
  • Obesity, Morbid

Interventions

DIAGNOSTIC_TEST

Oral Glucose Tolerance Test

Standard test of glucose tolerance with ingestion of 75 g glucose followed by blood sampling.

DIAGNOSTIC_TEST

Hyperglycemic clamp with infusion of saline, GLP-1 or GIP

Blood glucose kept at 15 mmol/L via iv 20% glucose infusions. Primed co-infusion of either: * Saline * GLP-1 (Prime dose 6 pmol/kg, infusion 1 pmol/kg/min) * GIP (Prime dose 3 pmol/kg, infusion 1.5 pmol/kg/min).

Sponsors & Collaborators

  • University of Copenhagen

    collaborator OTHER

  • Hvidovre University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2022-01-31
Completion
2022-03-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04782999 on ClinicalTrials.gov