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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