NCT03526289

Brief Summary

The primary aim of the study is to evaluate how GIP receptor activation influence food intake and mechanisms regulating food intake in obese individuals with type 2 diabetes that are in steady treatment with metformin and a GLP-1 receptor agonist.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable type-2-diabetes-mellitus

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2017

Completed
15 days until next milestone

Study Start

First participant enrolled

November 8, 2017

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 16, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2018

Completed
Last Updated

December 5, 2018

Status Verified

December 1, 2018

Enrollment Period

12 months

First QC Date

October 24, 2017

Last Update Submit

December 4, 2018

Conditions

Type 2 Diabetes MellitusOverweight and Obesity

Outcome Measures

Primary Outcomes (1)

  • food intake

    food intake (kJ) eaten from an ad libitum meal of pasta bolognese

    time point 300-330 minutes

Secondary Outcomes (14)

  • Appetite

    time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes

  • satiety

    time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes

  • prospective food consumption

    time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes

  • fullness

    time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes

  • Thirst

    time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes

  • +9 more secondary outcomes

Study Arms (2)

GIP infusion

ACTIVE COMPARATOR

5 hours of continuously GIP1-42 infusion

Biological: GIP1-42 infusion

Saline

PLACEBO COMPARATOR

5 hours of continuously saline infusion

Other: Saline

Interventions

GIP1-42 infusionBIOLOGICAL

5-hour GIP1-42 infusion (time point 0-300 minutes)

GIP infusion
SalineOTHER

5-hour infusion of saline (placebo) (time point 0-300 minutes)

Saline

Eligibility Criteria

Age18 Years - 70 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmale fænotype
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Caucasian men
  • Age between 18 and 70 years
  • Body mass index (BMI) between 25 and 40 kg/m2
  • Type 2 diabetes (diagnosed according to the criteria of the World Health Organization) with HbA1c \<69 mM (\<8.5 %)
  • In stable treatment for ≥3 months with metformin ≥1 g and a GLP-1 receptor agonist.
  • Informed consent

You may not qualify if:

  • Anaemia (haemoglobin outside normal range)
  • Any current or prior gastrointestinal disease that may interfere with the endpoint variables
  • Liver disease (alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) \> 2 times normal values) or history of hepatobiliary disorder.
  • Nephropathy (serum creatinine above normal range and/or albuminuria).
  • Anorexia, bulimia or binge eating disorder
  • Allergy or intolerance to ingredients included in the standardised meals
  • Tobacco smoking
  • Treatment with other glucose lowering drugs than GLP-1 receptor agonists and metformin.
  • Any regular drug treatment (besides metformin and GLP-1 receptor agonists) that cannot be discontinued for a minimum of 12 hours
  • Any physical or psychological condition that the investigator feels would interfere with trial participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for diabetes research

Hellerup, DK-2900, Denmark

Location

Related Publications (1)

  • Bergmann NC, Gasbjerg LS, Heimburger SM, Krogh LSL, Dela F, Hartmann B, Holst JJ, Jessen L, Christensen MB, Vilsboll T, Lund A, Knop FK. No Acute Effects of Exogenous Glucose-Dependent Insulinotropic Polypeptide on Energy Intake, Appetite, or Energy Expenditure When Added to Treatment With a Long-Acting Glucagon-Like Peptide 1 Receptor Agonist in Men With Type 2 Diabetes. Diabetes Care. 2020 Mar;43(3):588-596. doi: 10.2337/dc19-0578. Epub 2020 Jan 16.

    PMID: 31949084DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2OverweightObesity

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor

Study Record Dates

First Submitted

October 24, 2017

First Posted

May 16, 2018

Study Start

November 8, 2017

Primary Completion

October 24, 2018

Study Completion

October 24, 2018

Last Updated

December 5, 2018

Record last verified: 2018-12

Locations

DK(1)