Clinical trial NCT01579981: The Importance of GLP-1 in Post RYGB Improvement in Glycaemic Control Type 2 Diabetic Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: RYGB
Bariatric Surgery
Glucagon-like-peptide 1
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2012-04-18
Enrollment: 9
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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

Eligibility criteria: 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.

Primary outcomes:
measure: Beta cell glucose sensitivity
timeFrame: 1 week and 3 months after RYGB
Secondary outcomes:
measure: Glucose tolerance
timeFrame: 1 week and 3 months after RYGB
measure: Ad libitum food intake
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Dept. of Endocrinology, Hvidovre Hospital
Study officials:
affiliation: Dept. of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark
name: Sten Madsbad, MD, DMSc
role: STUDY_CHAIR
affiliation: Dept. of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark
name: Nils B Jørgensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Palleja A, Kashani A, Allin KH, Nielsen T, Zhang C, Li Y, Brach T, Liang S, Feng Q, Jorgensen NB, Bojsen-Moller KN, Dirksen C, Burgdorf KS, Holst JJ, Madsbad S, Wang J, Pedersen O, Hansen T, Arumugam M. Roux-en-Y gastric bypass surgery of morbidly obese patients induces swift and persistent changes of the individual gut microbiota. Genome Med. 2016 Jun 15;8(1):67. doi: 10.1186/s13073-016-0312-1.
citation: Lindegaard KK, Jorgensen NB, Just R, Heegaard PM, Madsbad S. Effects of Roux-en-Y gastric bypass on fasting and postprandial inflammation-related parameters in obese subjects with normal glucose tolerance and in obese subjects with type 2 diabetes. Diabetol Metab Syndr. 2015 Feb 24;7:12. doi: 10.1186/s13098-015-0012-9. eCollection 2015.