Investigating the effects of amylin on bone metabolism in type 1 diabetes
The Role of Amylin in Bone Metabolism
This study is testing whether a medication called pramlintide can improve bone health in people with type 1 diabetes by looking at changes in certain markers in their blood.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University Hospital, Gentofte, Copenhagen Academic / other |
| Locations | 1 site (Hellerup, Capital Region) |
| Trial ID | NCT06186063 on ClinicalTrials.gov |
What this trial studies
This clinical study examines how an amylin analogue, pramlintide, affects bone metabolism markers in individuals with type 1 diabetes compared to healthy controls. Using a randomized, double-blind, placebo-controlled crossover design, the study will administer pramlintide and saline infusions to participants during fasting euglycemic conditions. The primary focus is on measuring changes in circulating levels of CTX-1 and P1NP, which indicate bone resorption and formation, respectively. Secondary endpoints will assess various metabolic markers to provide a comprehensive understanding of amylin's role in bone health.
Who should consider this trial
Good fit: Ideal candidates are Caucasian individuals aged 18 to 60 with type 1 diabetes and specific metabolic criteria.
Not a fit: Patients with significant comorbidities, such as liver disease or recent fractures, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new insights into managing bone health in patients with type 1 diabetes.
How similar studies have performed: While the specific approach of using pramlintide in this context is novel, related studies on amylin's effects have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hellerup, Capital Region
- Center for Clinical Metabolic Research, Gentofte Hospital — Hellerup, Capital Region, Denmark (Recruiting)
Study contacts
- Principal investigator: Filip K. Knop, Professor, MD, PhD — Center for Clinical Metabolic Research, Gentofte Hospital, Denmark
- Study coordinator: Mathilde K. Preskou, MD
- Email: emma.mathilde.kirsmeier.preskou.01@regionh.dk
- Phone: +45 2349 6823
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.