Type 1 Diabetes Mellitus
Conditions
Brief summary
Investigate GIP effects on biomarkers involved in bone homeostasis
Interventions
OTHERGIP
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.
OTHERGLP-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.
OTHERSaline
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.
Sponsors
Mikkel Christensen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Randomized, double-blinded, cross-over study with 5 study days.
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| C-terminal telopeptide of type I collagen (CTX). | 30 minutes intervals, time 0 up to 120 min |
Secondary
| Measure | Time frame |
|---|---|
| Parathyroid hormone (PTH) | 30 minutes intervals, time 0 up to 120 min |
| N-terminal propeptide of type 1 procollagen (P1NP). | 30 minutes intervals, time 0 up to 120 min |
Outcome results
None listed