Glucose-Dependent Insulinotropic Polypeptide - Effects on Markers of Bone Turnover in Patients With Type 1 Diabetes

Mikkel Christensen

Status: Completed

Conditions: Type 1 Diabetes Mellitus

Treatments: Other: GLP-1; Other: GIP; Other: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03195257

GIP-T1DM-BTM

Details and patient eligibility

About

Investigate GIP effects on biomarkers involved in bone homeostasis

Enrollment: 10 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients with type 1 diabetes (positive islet cell/ glutamic acid decarboxylase-65 antibodies)
• Patients without measurable beta cell function (i.e. incremental C-peptide below detection limit (<0.16 nmol/l) following an 5 g-iv-arginine stimulation test,

Exclusion criteria

• HbA1c >9% (75 mmol/mol),
• standard plasma biochemical measurements outside normal reference interval (alanine aminotransferase, bilirubin, thyroid-stimulating hormone, hemoglobin, creatinine, and spot urine albumin-creatinine ratio);
• an abnormal state of hypoglycemia awareness,
• significant diabetic complications (i.e. proliferative diabetic retinopathy, neuropathy, severe atherosclerosis, heart disease) and,
• treatment with medication (besides insulin) that could not be paused for 12 hours up to and during the days of the experiments.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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10 participants in 5 patient groups, including a placebo group

Hypoglycemia-saline

Placebo Comparator group

Treatment:

Other: Saline

Hypoglycemia-GIP

Experimental group

Treatment:

Other: GIP

Hypoglycemia-GLP-1

Active Comparator group

Treatment:

Other: GLP-1

Hyperglycemia-GIP

Experimental group

Treatment:

Other: GIP

Hyperglycemia-Saline

Placebo Comparator group

Treatment:

Other: Saline