Status:
RECRUITING
The Role of Amylin in Bone Metabolism
Lead Sponsor:
Filip Krag Knop
Conditions:
Bone Diseases, Metabolic
Type 1 Diabetes
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The clinical study aims to investigate the effect of the intravenously administrated amylin analogue (pramlintide) on the circulating levels of C-terminal telopeptide of type I collagen (CTX-1) (a mar...
Detailed Description
Using a randomised double blinded placebo-controlled crossover design the investigators will evaluate the effects of the intravenously administrated amylin analogue (pramlintide) on circulating levels...
Eligibility Criteria
Inclusion
- Inclusion criteria type 1 diabetes:
- Caucasian ethnicity
- Age between 18 and 60 years
- BMI between 18.5 and 27 kg/m2
- Type 1 diabetes (diagnosed according to the criteria of the World Health Organization) with HbA1c \<69 mmol/mol (\<8.5%) and
- Type 1 diabetes duration of 2-20 years
- C-peptide negative (stimulated C-peptide ≤30 pmol/l)
- Treatment with a stable basal-bolus or insulin pump regimen for ≥3 months
- Normal vitamin D (\>50 nmol/l)
- Informed consent
- Exclusion criteria type 1 diabetes:
- Anaemia (haemoglobin below normal range)
- Liver disease (ALAT and/or ASAT \>2 times normal values) or history of hepatobiliary disorder
- Nephropathy (eGFR \<60 ml/min/1,73m2 and/or microalbuminuria)
- Microvascular complications except non-proliferative retinopathy
- Treatment with anti-osteoporosis medication or glucocorticoids
- Fractures within the last 6 months
- For women: currently perimenopausal or postmenopausal
- Diseases affecting calcium metabolism (e.g. hypoparathyroidism, hyperparathyroidism, osteoporosis, vitamin D deficiency and cancer)
- Pregnancy or breastfeeding
- Any physical or psychological condition that the investigator feels would interfere with trial participation
- Treatment with any glucose-lowering drugs beside insulin, treatment with medication against osteoporosis or treatment with any form of glucocorticoids
- Inclusion criteria healthy controls:
- Caucasian ethnicity
- Age between 18 and 60 years
- BMI between 18.5 and 27 kg/m2
- Fasting plasma glucose ≤7.0 mmol/l and glycated haemoglobin (HbA1c) \<48 mmol/mol
- Normal blood haemoglobin (8.3-10.5 mmol/l (males) and 7.3 - 9.5 mmol/l (females))
- Normal plasma vitamin D (\>50 nmol/l)
- Informed consent
- Exclusion criteria healthy controls:
- Any form of diabetes (according to World Health Organization criteria)
- Anaemia (haemoglobin below normal range)
- Nephropathy (eGFR \<60 ml/min/1,73m2 and/or microalbuminuria)
- Known liver disease and/or alanine transaminase (ALAT) or aspartate transaminase (ASAT) \>2 × upper normal limit
- Any fractures within the last 6 months
- For women: currently perimenopausal or postmenopausal
- Diseases affecting calcium metabolism (e.g. hypoparathyroidism, hyperparathyroidism, osteoporosis, vitamin D deficiency and cancer)
- Pregnancy or breastfeeding
- Any condition considered incompatible with participation by the investigators
Exclusion
Key Trial Info
Start Date :
February 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06186063
Start Date
February 12 2024
End Date
August 1 2024
Last Update
February 21 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Center for Clinical Metabolic Research, Gentofte Hospital
Hellerup, Capital Region, Denmark, 2900