The Role of Amylin in Bone Metabolism

NCT06186063 | Recruiting

• 1 other identifier: H-22050946
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 marker of bone resorption) and N-terminal propeptide of type I procollagen (P1NP) (a marker of bone formation) in individuals with type 1 diabetes and matched healthy controls during fasting euglycemic conditions.

Conditions

Bone Diseases, Metabolic; Type 1 Diabetes

Outcome Measures

Primary Outcomes (2)

• Relative changes in the plasma levels of C-terminal telopeptide of type I collagen (CTX-1)

  The changes in plasma concentrations will be assessed by the total and incremental (baseline-subtracted) area under the curve for plasma CTX-1 as well as %-changes from baseline including nadir.

  From -15 minutes to 180 minutes

• Relative changes in the plasma levels of N-terminal propeptide of type I procollagen (P1NP)

  The changes in plasma concentrations will be assessed by the total and incremental (baseline-subtracted) area under the curve for plasma P1NP as well as %-changes from baseline including nadir.

  From -15 minutes to 180 minutes

Secondary Outcomes (11)

• Changes in plasma concentrations of glucagon.

  From -15 minutes to 180 minutes

• Changes in plasma concentrations of insulin.

  From -15 minutes to 180 minutes

• Changes in plasma concentrations of C-peptide.

  From -15 minutes to 180 minutes

• Changes in plasma concentrations of glucose.

  From -15 minutes to 180 minutes

• Changes in plasma concentrations of glucose-dependent insulinotropic polypeptide (GIP).

  From -15 minutes to 180 minutes

Study Arms (2)

Pramlintide infusion

EXPERIMENTAL

A stable amylin analogue.

Other: Pramlintide

Placebo infusion

PLACEBO COMPARATOR

Isotonic saline (0.9% NaCl).

Other: Placebo (saline) infusion

Interventions

Pramlintide OTHER

At time 0 min, continuous infusion of a stable amylin analogue (pramlintide) will be initiated at a rate of 3.0 pmol/kg/min. The infusion will be terminated after 180 minutes.

Pramlintide infusion

Placebo (saline) infusion OTHER

At time 0 min, continuous infusion of isotonic saline will be initiated at a rate of 150 ml/h. The infusion will be terminated after 180 minutes.

Placebo infusion

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Filip Krag Knop: lead

Study Sites (1)

Center for Clinical Metabolic Research, Gentofte Hospital

Hellerup, Capital Region, 2900, Denmark

RECRUITING

MeSH Terms

Conditions

Bone Diseases, Metabolic; Diabetes Mellitus, Type 1

Interventions

pramlintide; Sodium Chloride

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Filip K. Knop, Professor, MD, PhD

  Center for Clinical Metabolic Research, Gentofte Hospital, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mathilde K. Preskou, MD

CONTACT

+45 2349 6823; emma.mathilde.kirsmeier.preskou.01@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, MD, PhD

Model Details: The investigators apply a randomized, double-blinded, placebo-controlled, crossover design.

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: December 29, 2023
• Study Start: February 12, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: February 21, 2024

Record last verified: 2024-02

Locations

DK (1)