Glucose-Dependent Insulinotropic Polypeptide - Effects on Markers of Bone Turnover in Patients With Type 1 Diabetes
Not Applicable
Completed
- Conditions
- Type 1 Diabetes Mellitus
- Interventions
- Other: SalineOther: GLP-1Other: GIP
- Registration Number
- NCT03195257
- Lead Sponsor
- Mikkel Christensen
- Brief Summary
Investigate GIP effects on biomarkers involved in bone homeostasis
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 10
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Hypoglycemia-saline Saline - Hypoglycemia-GLP-1 GLP-1 - Hypoglycemia-GIP GIP - Hyperglycemia-GIP GIP - Hyperglycemia-Saline Saline -
- Primary Outcome Measures
Name Time Method C-terminal telopeptide of type I collagen (CTX). 30 minutes intervals, time 0 up to 120 min
- Secondary Outcome Measures
Name Time Method N-terminal propeptide of type 1 procollagen (P1NP). 30 minutes intervals, time 0 up to 120 min Parathyroid hormone (PTH) 30 minutes intervals, time 0 up to 120 min