Glucose-Dependent Insulinotropic Polypeptide – Effects on Markers of Bone Turnover in Patients With Type 1 Diabetes
Overview
Investigate GIP effects on biomarkers involved in bone homeostasis
Full Title of Study: “Glucose-Dependent Insulinotropic Polypeptide – Effects on Markers of Bone Turnover in Patients With Type 1 Diabetes”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Basic Science
- Masking: Triple (Participant, Care Provider, Investigator)
- Study Primary Completion Date: December 1, 2016
Interventions
- Other: GIP
- On 3 matched days with ‘hypoglycemia’ (i.e. plasma glucose clamped between 3-7 mol/L for 120 minutes) either GIP (4 pmol/kg/min), glucagon-like-peptide-1 (GLP-1) (1 pmol/kg/min) or placebo (saline) was administered; and on 2 separately matched days with ‘hyperglycemia’ (i.e. clamped at 12 mmol/L for 90 minutes) either GIP (4 pmol/kg/min) or saline was administered.
- Other: GLP-1
- On 3 matched days with ‘hypoglycemia’ (i.e. plasma glucose clamped between 3-7 mol/L for 120 minutes) either GIP (4 pmol/kg/min), glucagon-like-peptide-1 (GLP-1) (1 pmol/kg/min) or placebo (saline) was administered; and on 2 separately matched days with ‘hyperglycemia’ (i.e. clamped at 12 mmol/L for 90 minutes) either GIP (4 pmol/kg/min) or saline was administered.
- Other: Saline
- On 3 matched days with ‘hypoglycemia’ (i.e. plasma glucose clamped between 3-7 mol/L for 120 minutes) either GIP (4 pmol/kg/min), glucagon-like-peptide-1 (GLP-1) (1 pmol/kg/min) or placebo (saline) was administered; and on 2 separately matched days with ‘hyperglycemia’ (i.e. clamped at 12 mmol/L for 90 minutes) either GIP (4 pmol/kg/min) or saline was administered.
Arms, Groups and Cohorts
- Placebo Comparator: Hypoglycemia-saline
- Experimental: Hypoglycemia-GIP
- Active Comparator: Hypoglycemia-GLP-1
- Experimental: Hyperglycemia-GIP
- Placebo Comparator: Hyperglycemia-Saline
Clinical Trial Outcome Measures
Primary Measures
- C-terminal telopeptide of type I collagen (CTX).
- Time Frame: 30 minutes intervals, time 0 up to 120 min
Secondary Measures
- Parathyroid hormone (PTH)
- Time Frame: 30 minutes intervals, time 0 up to 120 min
- N-terminal propeptide of type 1 procollagen (P1NP).
- Time Frame: 30 minutes intervals, time 0 up to 120 min
Participating in This Clinical Trial
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.
Gender Eligibility: Male
Minimum Age: 18 Years
Maximum Age: 50 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Mikkel Christensen
- Provider of Information About this Clinical Study
- Sponsor-Investigator: Mikkel Christensen, Associate Professor, Principal Investigator – University Hospital, Gentofte, Copenhagen
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