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The Importance of GLP-1 in Post RYGB Improvement in Glycaemic Control Type 2 Diabetic Subjects

The Exaggerated Glucagon-like Peptide-1 Response is Important for the Improved β-cell Function and Glucose Tolerance After Roux-en-Y Gastric Bypass in Patients With Type 2 Diabetes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01579981
Enrollment
9
Registered
2012-04-18
Start date
2012-04-30
Completion date
2012-11-30
Last updated
2017-02-10

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

Conditions

Type 2 Diabetes

Keywords

RYGB, Bariatric Surgery, Glucagon-like-peptide 1

Brief summary

After Roux-en-Y gastric bypass (RYGB) meal induced GLP-1 secretion is dramatically increased, while beta-cell function is increased in type 2 diabetic (T2D) subjects. The aim of this study is to establish causality between the two observations. By meal testing 10 T2D subjects with infusion of saline or exendin (9-39), a GLP-1R specific blocker, before and 1 week and 3 months after RYGB we hope to demonstrate the role of GLP-1 in improveing beta-cell function and maintaing glucose tolerance after RYGB in T2D subjects. Furthermore, effects of GLP-1 rec blockade before and after RYGB on ad libitum energy intake is examined

Detailed description

After Roux-en-Y gastric bypass (RYGB) meal induced GLP-1 secretion is dramatically increased, while beta-cell function is increased in type 2 diabetic (T2D) subjects. The aim of this study is to establish causality between the two observations. By meal testing 10 T2D subjects with infusion of saline or exendin (9-39), a GLP-1R specific blocker, before and 1 week and 3 months after RYGB we hope to demonstrate the role of GLP-1 in improveing beta-cell function and maintaing glucose tolerance after RYGB in T2D subjects. Furthermore, effects of GLP-1 rec blockade before and after RYGB on ad libitum energy intake is examined

Interventions

PROCEDURERoux-en-Y Gastric Bypass

On two separate experimental days before, 1 wk, and 3 months after RYGB, subjects are given a liquid meal test during Exendin 9-39 (900 pmol/min/kg)or saline infusion. The order of the infusions is randomized. At end of study day an ad libitum meal is served.

Sponsors

Hvidovre University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Fasting glucose \> 7.0 mM, 2h glucose after OGTT \> 11.0 mM. BMI \> 35. HbA1c \< 8.5%. Fasting C-peptide \> 700 pM. Elegible for RYGB.

Exclusion criteria

* Dysregulated hypothyroidism, hyperthyroidism, anaemia.

Design outcomes

Primary

MeasureTime frameDescription
Beta cell glucose sensitivity1 week and 3 months after RYGBchange in prehepatic insulin secretionrate relative to glucose increments

Secondary

MeasureTime frameDescription
Glucose tolerance1 week and 3 months after RYGBchange in AUC glucose
Ad libitum food intake3 months after surgeryChange in amount of calories ingested

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026