NCT01579981

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Apr 2012

Shorter than P25 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 18, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

February 10, 2017

Status Verified

February 1, 2017

Enrollment Period

7 months

First QC Date

April 16, 2012

Last Update Submit

February 9, 2017

Conditions

Type 2 Diabetes

Keywords

RYGBBariatric SurgeryGlucagon-like-peptide 1

Outcome Measures

Primary Outcomes (1)

  • Beta cell glucose sensitivity

    change in prehepatic insulin secretionrate relative to glucose increments

    1 week and 3 months after RYGB

Secondary Outcomes (2)

  • Glucose tolerance

    1 week and 3 months after RYGB

  • Ad libitum food intake

    3 months after surgery

Interventions

Roux-en-Y Gastric BypassPROCEDURE

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.

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Dysregulated hypothyroidism, hyperthyroidism, anaemia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Endocrinology, Hvidovre Hospital

Hvidovre, DK-2650, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 27306058DERIVED

  • 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.

    PMID: 25763111DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Bariatric SurgeryBariatricsObesity ManagementTherapeuticsGastroenterostomyAnastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Study Officials

  • Sten Madsbad, MD, DMSc

    Dept. of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark

    STUDY CHAIR

  • Nils B Jørgensen, MD

    Dept. of Endocrinology, Hvidovre Hospital, Hvidovre, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Klinisk Assistent

Study Record Dates

First Submitted

April 16, 2012

First Posted

April 18, 2012

Study Start

April 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

February 10, 2017

Record last verified: 2017-02

Locations

DK(1)