Glucose-dependent Insulinotropic Polypeptide as a Safeguard Against Hypoglycemia in Patients With Type 1 Diabetes

NCT03556098 | Completed DMC

• 1 other identifier: H-18002707
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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 patients with T1D.

Conditions

Diabetes Mellitus, Type 1

Keywords

Diabetes Mellitus, Type 1; Hypoglycemia; Gastric Inhibitory Polypeptide; Glucagon; Incretin

Outcome Measures

Primary Outcomes (1)

• plasma glucose concentration

  plasma glucose excursions and plasma glucose nadir

  At times (minute): - 30, - 15, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 on study days

Secondary Outcomes (14)

• Glucose regulatory hormones

  At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days

• Incretin hormones

  At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days

• GIP[3-30]

  At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days

• Free fatty acids (FFA)

  At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days

• Blood analysis of paracetamol as an assessment of gastric emptying

  At times (minute): - 30, 0, 15, 30, 60, 90, 120, 150, 180, 210, 240 on study days

Study Arms (3)

GIP

ACTIVE COMPARATOR

Infusion of Glucose-dependent insulinotropic peptide

Drug: glucose-dependent insulinotropic peptide

GIP[3-30]

ACTIVE COMPARATOR

Infusion of GIP\[3-30\]

Drug: Glucose-Dependent Insulin-Releasing Hormone[3-30]

Saline

PLACEBO COMPARATOR

Infusion of saline

Drug: Saline Solution

Interventions

glucose-dependent insulinotropic peptide DRUG

Infusion of GIP

GIP

Glucose-Dependent Insulin-Releasing Hormone[3-30] DRUG

Infusion of GIP antagonist GIP\[3-30\]

GIP[3-30]

Saline Solution DRUG

Infusion of Saline

Also known as: Placebo

Saline

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Caucasian men
• Body mass index between 20-27 kg/m\^2
• T1D (diagnosed according to the criteria of the World Health Organization) with HbA1c\<69 mmol/l (\<8,5%)
• T1D duration between 2-20 years
• Stimulated C-peptide ≤ 100 pmol/mL)
• Treatment with a stable basal bolus or insulin pump regimen ≥ 3 months
• Informed consent

You may not qualify if:

• Anemia (hemoglobin below normal range)
• Liver disease (ALAT and/or ASAT \>2 times normal values) or history of hepatobiliary disorder
• Nephropathy (serum creatinine above normal range and/or albuminuria)
• Allergy or intolerance to ingredients included in the standardized meals
• Prior myocardial infarction or other cardiac events
• Any physical or psychological condition that the investigator fells would interfere with trial participation
• Treatment with any glucose-lowering drugs beside insulin

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen: lead

Study Sites (1)

Steno Diabetes Center Copenhagen, Clinical Metabolic Physiology

Hellerup, 2900, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia

Interventions

Gastric Inhibitory Polypeptide; Saline Solution

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Filip K Knop, MD, PhD

  Steno Diabetes Center Copenhagen, Clinical Metabolic Physiology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The peptides/placebo is prepared, in a randomized fashion, by a laboratory assistant..
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, PhD student, Prinicipal Investigator

Model Details: Double blinded, randomized, cross-over study

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: June 14, 2018
• Study Start: February 22, 2019
• Primary Completion: February 11, 2020
• Study Completion: February 11, 2020
• Last Updated: May 10, 2021

Record last verified: 2021-05

Locations

DK (1)