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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03195257
Recruitment Status : Completed
First Posted : June 22, 2017
Last Update Posted : June 23, 2017
Sponsor:
Information provided by (Responsible Party):
Mikkel Christensen, University Hospital, Gentofte, Copenhagen

Brief Summary:
Investigate GIP effects on biomarkers involved in bone homeostasis

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Other: GIP Other: GLP-1 Other: Saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Randomized, double-blinded, cross-over study with 5 study days.
Primary Purpose: Basic Science
Official Title: Glucose-Dependent Insulinotropic Polypeptide - Effects on Markers of Bone Turnover in Patients With Type 1 Diabetes
Actual Study Start Date : November 17, 2012
Actual Primary Completion Date : December 1, 2016
Actual Study Completion Date : December 1, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Placebo Comparator: Hypoglycemia-saline 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.
Other Name: placebo

Experimental: Hypoglycemia-GIP 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 Name: Glucose-Dependent Insulinotropic Polypeptide

Active Comparator: Hypoglycemia-GLP-1 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 Name: glucagon-like-peptide-1

Experimental: Hyperglycemia-GIP 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 Name: Glucose-Dependent Insulinotropic Polypeptide

Placebo Comparator: Hyperglycemia-Saline 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.
Other Name: placebo




Primary Outcome Measures :
  1. C-terminal telopeptide of type I collagen (CTX). [ Time Frame: 30 minutes intervals, time 0 up to 120 min ]

Secondary Outcome Measures :
  1. Parathyroid hormone (PTH) [ Time Frame: 30 minutes intervals, time 0 up to 120 min ]
  2. N-terminal propeptide of type 1 procollagen (P1NP). [ Time Frame: 30 minutes intervals, time 0 up to 120 min ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mikkel Christensen, Associate Professor, Principal Investigator, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT03195257    
Other Study ID Numbers: GIP-T1DM-BTM
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: June 23, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Glucagon
Gastric Inhibitory Polypeptide
Glucagon-Like Peptide 1
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins