Incretin Hormone Antagonism After Bariatric Surgery

NCT ID: NCT03950245

Last Updated: 2022-02-01

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2021-04-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Using the glucagon-like peptide-1 (GLP-1) antagonist exendin(9-39) and the glucose-dependent insulinotropic peptide (GIP) antagonist GIP(3-30), the purpose of this study is to clarify the importance of endogenous GLP-1 and GIP for postprandial glucose metabolism after RYGB and SG in subjects with normal glucose tolerance. We hypothesize that GLP-1 is more important after RYGB, and GIP is more important after SG, for postprandial glucose tolerance and beta-cell function. A group of un-operated subjects with normal glucose tolerance will serve as controls.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bariatric Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Gastric bypass operated patients

Four test days in a randomized, patient-blinded, cross-over design

Group Type OTHER

Placebo

Intervention Type OTHER

Four-hour liquid mixed meal tests and a subsequent ad libitum meal during saline infusion.

GLP-1 antagonism

Intervention Type OTHER

Four-hour liquid mixed meal tests and a subsequent ad libitum meal during exendin 9-39 and saline infusion.

GIP antagonism

Intervention Type OTHER

Four-hour liquid mixed meal tests and a subsequent ad libitum meal during GIP(3-30) and saline infusion.

GLP-1 and GIP antagonism

Intervention Type OTHER

Four-hour liquid mixed meal tests and a subsequent ad libitum meal during exendin and GIP(3-30) infusion.

Sleeve gastrectomy operated patients

Four test days in a randomized, patient-blinded cross-over, design

Group Type OTHER

Placebo

Intervention Type OTHER

Four-hour liquid mixed meal tests and a subsequent ad libitum meal during saline infusion.

GLP-1 antagonism

Intervention Type OTHER

Four-hour liquid mixed meal tests and a subsequent ad libitum meal during exendin 9-39 and saline infusion.

GIP antagonism

Intervention Type OTHER

Four-hour liquid mixed meal tests and a subsequent ad libitum meal during GIP(3-30) and saline infusion.

GLP-1 and GIP antagonism

Intervention Type OTHER

Four-hour liquid mixed meal tests and a subsequent ad libitum meal during exendin and GIP(3-30) infusion.

Un-operated controls

Four test days in a randomized, patient-blinded cross-over, design

Group Type OTHER

Placebo

Intervention Type OTHER

Four-hour liquid mixed meal tests and a subsequent ad libitum meal during saline infusion.

GLP-1 antagonism

Intervention Type OTHER

Four-hour liquid mixed meal tests and a subsequent ad libitum meal during exendin 9-39 and saline infusion.

GIP antagonism

Intervention Type OTHER

Four-hour liquid mixed meal tests and a subsequent ad libitum meal during GIP(3-30) and saline infusion.

GLP-1 and GIP antagonism

Intervention Type OTHER

Four-hour liquid mixed meal tests and a subsequent ad libitum meal during exendin and GIP(3-30) infusion.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo

Four-hour liquid mixed meal tests and a subsequent ad libitum meal during saline infusion.

Intervention Type OTHER

GLP-1 antagonism

Four-hour liquid mixed meal tests and a subsequent ad libitum meal during exendin 9-39 and saline infusion.

Intervention Type OTHER

GIP antagonism

Four-hour liquid mixed meal tests and a subsequent ad libitum meal during GIP(3-30) and saline infusion.

Intervention Type OTHER

GLP-1 and GIP antagonism

Four-hour liquid mixed meal tests and a subsequent ad libitum meal during exendin and GIP(3-30) infusion.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age \> 18 years
* RYGB or SG operation \> 12 months prior to inclusion
* Weight stable (± 3 kg during the last month)
* HbA1c \< 48 mmol/mol before surgery, and no history of diabetes
* HbA1c \< 48 mmol/mol and fasting plasma glucose \< 6.1 mmol/l at inclusion


* Age \> 18 years
* no former RYGB- or SG operation
* Weight stable (± 3 kg during the last month)
* HbA1c \< 48 mmol/mol, fasting plasma glucose \< 6.1 mmol/l and no history of diabetes

Exclusion Criteria

* Thyrotoxicosis or inadequately treated hypothyreosis
* Hemoglobin \< 6.5 mmol/l at inclusion
* Pregnancy or breast feeding
* Medication affecting the planned examinations

Matching between groups

* Age
* Sex
* BMI at inclusion and for surgery groups also pre-surgery BMI
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Morten Gadegaard Hindsø, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kirstine N Bojsen-Møller, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Endocrinology, Hvidovre Hospital, Denmark

Morten G Hindsø, MD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Endocrinology, Hvidovre Hospital, Denmark

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Endocrinology

Hvidovre, , Denmark

Site Status

Hvidovre Hospital

Hvidovre, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MH-INKA-BAR-19

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Impact GLP-1 Agonists Following Bariatric
NCT06132477 RECRUITING PHASE4
Mechanisms of Post-Bariatric Hypoglycemia
NCT04428866 ACTIVE_NOT_RECRUITING
GLP1R-imaging in Hypoglycemia
NCT03182192 RECRUITING PHASE1