NCT03734718

Brief Summary

In the present project the investigators will evaluate whether glucagonotropic properties of the gut-derived incretin hormone glucose-dependent insulinotropic polypeptide (GIP) may be utilized as a safeguard against hypoglycemia in the daily life of participants with type 1 Diabetes

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

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 22, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 8, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2019

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

6 months

First QC Date

October 22, 2018

Last Update Submit

January 23, 2020

Conditions

Diabetes Mellitus, Type 1Hypoglycemia

Keywords

Gastric Inhibitory PolypeptideDiabetes Mellitus, Type 1HypoglycemiaGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesGlucagonIncretin

Outcome Measures

Primary Outcomes (1)

  • Blood glucose

    Time spent in hypoglycemia, near-normoglycemia and hyperglycemia

    an average of 6 days

Secondary Outcomes (8)

  • Incretin hormones

    Evaluated at experimental day 0,1 and 6 of each intervention

  • Free fatty acids (FFA)

    Evaluated at experimental day 0,1 and 6 of each intervention

  • Fat mRNA

    At day 6, and 10 of the study

  • Fat Protein content

    Evaluated at experimental day 0,1 and 6 of each intervention

  • Blood pressure

    The first 24 hours of intervention and at experimental day 6

  • +3 more secondary outcomes

Study Arms (2)

Glucose-Dependent Insulinotropic Polypeptide

ACTIVE COMPARATOR

6-day continuous infusion of Glucose-Dependent Insulinotropic Polypeptide

Drug: GIP

Placebo

PLACEBO COMPARATOR

Saline

Drug: GIP

Interventions

GIPDRUG

Infusion of Glucose-dependent insulinotropic peptide

Glucose-Dependent Insulinotropic PolypeptidePlacebo

Eligibility Criteria

Age18 Years - 75 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsCaucasian men
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index between 20 and 27 kg/m2
  • T1D (diagnosed according to the criteria of the World Health Organization) with HbA1c \<69 mmol/mol (\<8.5%)
  • Treatment with a stable insulin regimen ≥3 months
  • T1D duration between 2 and 15years
  • C-peptide negative (C-peptide ≤ 16 ng/ml)
  • Informed consent

You may not qualify if:

  • Anemia (hemoglobin outside normal range)
  • Known liver disease and/or ALAT and/or ASAT \> 2 times normal values
  • Estimated glomerular filtration rate (eGFR) ≤60 ml/min/1.73 m2 or albuminuria
  • Prior Cardiovascular events and/or abnormal heart rate/blood pressure
  • Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to randomization
  • 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)

Steno Diabetes Center CopenhagenSteno Diabetes Center Copenhagen, Clinical Metabolic Physiology

Hellerup, 2800, Denmark

Location

Related Publications (3)

  • Gilliam-Vigh H, Suppli MP, Heimburger SMN, Lund AB, Knop FK, Ellegaard AM. Cholesin mRNA Expression in Human Intestinal, Liver, and Adipose Tissues. Nutrients. 2025 Feb 8;17(4):619. doi: 10.3390/nu17040619.

    PMID: 40004948DERIVED

  • Heimburger SMN, Hoe B, Nielsen CN, Bergman NC, Skov-Jeppesen K, Hartmann B, Holst JJ, Dela F, Overgaard J, Storling J, Vilsboll T, Dejgaard TF, Havelund JF, Gorshkov V, Kjeldsen F, Faergeman NJ, Madsen MR, Christensen MB, Knop FK. GIP Affects Hepatic Fat and Brown Adipose Tissue Thermogenesis but Not White Adipose Tissue Transcriptome in Type 1 Diabetes. J Clin Endocrinol Metab. 2022 Nov 25;107(12):3261-3274. doi: 10.1210/clinem/dgac542.

    PMID: 36111559DERIVED

  • Heimburger SMN, Hoe B, Nielsen CN, Bergmann NC, Hartmann B, Holst JJ, Vilsboll T, Dejgaard TF, Christensen MB, Knop FK. The effect of 6-day subcutaneous glucose-dependent insulinotropic polypeptide infusion on time in glycaemic range in patients with type 1 diabetes: a randomised, double-blind, placebo-controlled crossover trial. Diabetologia. 2021 Nov;64(11):2425-2431. doi: 10.1007/s00125-021-05547-8. Epub 2021 Aug 17.

    PMID: 34405256DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1HypoglycemiaGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Condition Hierarchy (Ancestors)

Diabetes MellitusNutritional and Metabolic DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
The peptides/placebo is prepared, in a randomized fashion, by a laboratory assistant.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: placebo-controlled, double-blinded, cross-over study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2018

First Posted

November 8, 2018

Study Start

June 1, 2019

Primary Completion

December 12, 2019

Study Completion

December 31, 2019

Last Updated

January 27, 2020

Record last verified: 2020-01

Locations

DK(1)