Back to resultsGlucose-Dependent Insulinotropic Polypeptide - Effects on Markers of Bone Turnover in Patients With Type 1 Diabetes
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
GIP
GLP-1
Saline
Sponsored by
About this trial
This is an interventional basic science trial for Type 1 Diabetes Mellitus
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Placebo Comparator
Experimental
Active Comparator
Experimental
Placebo Comparator
Arm Label
Hypoglycemia-saline
Hypoglycemia-GIP
Hypoglycemia-GLP-1
Hyperglycemia-GIP
Hyperglycemia-Saline
Arm Description
Outcomes
Primary Outcome Measures
C-terminal telopeptide of type I collagen (CTX).
Secondary Outcome Measures
Parathyroid hormone (PTH)
N-terminal propeptide of type 1 procollagen (P1NP).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03195257
Brief Title
Glucose-Dependent Insulinotropic Polypeptide - Effects on Markers of Bone Turnover in Patients With Type 1 Diabetes
Official Title
Glucose-Dependent Insulinotropic Polypeptide - Effects on Markers of Bone Turnover in Patients With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
November 17, 2012 (Actual)
Primary Completion Date
December 1, 2016 (Actual)
Study Completion Date
December 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mikkel Christensen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Investigate GIP effects on biomarkers involved in bone homeostasis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Randomized, double-blinded, cross-over study with 5 study days.
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hypoglycemia-saline
Arm Type
Placebo Comparator
Arm Title
Hypoglycemia-GIP
Arm Type
Experimental
Arm Title
Hypoglycemia-GLP-1
Arm Type
Active Comparator
Arm Title
Hyperglycemia-GIP
Arm Type
Experimental
Arm Title
Hyperglycemia-Saline
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
GIP
Other Intervention Name(s)
Glucose-Dependent Insulinotropic Polypeptide
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
GLP-1
Other Intervention Name(s)
glucagon-like-peptide-1
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Saline
Other Intervention Name(s)
placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
C-terminal telopeptide of type I collagen (CTX).
Time Frame
30 minutes intervals, time 0 up to 120 min
Secondary Outcome Measure Information:
Title
Parathyroid hormone (PTH)
Time Frame
30 minutes intervals, time 0 up to 120 min
Title
N-terminal propeptide of type 1 procollagen (P1NP).
Time Frame
30 minutes intervals, time 0 up to 120 min
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29099978
Citation
Christensen MB, Lund A, Calanna S, Jorgensen NR, Holst JJ, Vilsboll T, Knop FK. Glucose-Dependent Insulinotropic Polypeptide (GIP) Inhibits Bone Resorption Independently of Insulin and Glycemia. J Clin Endocrinol Metab. 2018 Jan 1;103(1):288-294. doi: 10.1210/jc.2017-01949.
Results Reference
derived
Learn more about this trial
Glucose-Dependent Insulinotropic Polypeptide - Effects on Markers of Bone Turnover in Patients With Type 1 Diabetes
We'll reach out to this number within 24 hrs