NCT03950245

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2021

Completed
Last Updated

February 1, 2022

Status Verified

January 1, 2022

Enrollment Period

1.8 years

First QC Date

May 13, 2019

Last Update Submit

January 31, 2022

Conditions

Bariatric Surgery

Keywords

glucagon-like peptide-1glucose-dependent insulinotropic polypeptideRoux-en-Y gastric bypasssleeve gastrectomygastric bypassbariatric surgeryglucosediabetesexendin(9-39)GIP(3-30)

Outcome Measures

Primary Outcomes (1)

  • iAUC glucose

    Main comparison between groups: delta iAUC glucose (iAUC exendin(9-39) test day - iAUC GIP(3-30) test day) in the RYGB group compared to the SG group

    240 minutes

Secondary Outcomes (1)

  • Beta-cell glucose sensitivity (β-GS)

    240 minutes

Study Arms (3)

Gastric bypass operated patients

OTHER

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

Other: PlaceboOther: GLP-1 antagonismOther: GIP antagonismOther: GLP-1 and GIP antagonism

Sleeve gastrectomy operated patients

OTHER

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

Other: PlaceboOther: GLP-1 antagonismOther: GIP antagonismOther: GLP-1 and GIP antagonism

Un-operated controls

OTHER

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

Other: PlaceboOther: GLP-1 antagonismOther: GIP antagonismOther: GLP-1 and GIP antagonism

Interventions

PlaceboOTHER

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

Gastric bypass operated patientsSleeve gastrectomy operated patientsUn-operated controls
GLP-1 antagonismOTHER

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

Gastric bypass operated patientsSleeve gastrectomy operated patientsUn-operated controls
GIP antagonismOTHER

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

Gastric bypass operated patientsSleeve gastrectomy operated patientsUn-operated controls
GLP-1 and GIP antagonismOTHER

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

Gastric bypass operated patientsSleeve gastrectomy operated patientsUn-operated controls

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years
  • Weight stable (± 3 kg during the last month)
  • HbA1c \< 48 mmol/mol before surgery, and no history of diabetes
  • 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

You may not qualify if:

  • Thyrotoxicosis or inadequately treated hypothyreosis
  • Pregnancy or breast feeding
  • Medication affecting the planned examinations
  • Matching between groups
  • Age
  • Sex

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Endocrinology

Hvidovre, 2650, Denmark

Location

Hvidovre Hospital

Hvidovre, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Glucagon-Like Peptide 1

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Kirstine N Bojsen-Møller, MD, PHD

    Dept. of Endocrinology, Hvidovre Hospital, Denmark

    PRINCIPAL INVESTIGATOR

  • Morten G Hindsø, MD

    Dept. of Endocrinology, Hvidovre Hospital, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 13, 2019

First Posted

May 15, 2019

Study Start

July 1, 2019

Primary Completion

April 16, 2021

Study Completion

April 16, 2021

Last Updated

February 1, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(2)