The Role of Amylin in Bone Metabolism

Launched by FILIP KRAG KNOP · Dec 15, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how a medication called pramlintide, which is similar to a natural hormone called amylin, affects bone health in people with type 1 diabetes. Researchers want to see if this treatment can change the levels of certain markers in the blood that indicate how bones are being broken down and formed. They will compare the results from participants with type 1 diabetes to those from healthy individuals during times when their blood sugar levels are stable.

To participate, individuals with type 1 diabetes need to be between 18 and 60 years old, of Caucasian ethnicity, and have had diabetes for 2 to 20 years. They should also have certain levels of blood sugar and body weight. Healthy volunteers will also be required to meet similar age and ethnicity criteria but must not have diabetes or any other significant health issues. Participants can expect to receive the medication through an intravenous (IV) line in a controlled setting, and their health will be monitored throughout the trial. This study is currently recruiting participants, so anyone interested should consider talking to their healthcare provider for more information.

Gender

ALL

Eligibility 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