The Role of Amylin in Bone Metabolism

Not Applicable

Recruiting

• Conditions: Bone Diseases, Metabolic; Type 1 Diabetes
• Interventions: Other: Pramlintide; Other: Placebo (saline) infusion

• Registration Number: NCT06186063
• Lead Sponsor: Filip Krag Knop

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.

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 of CTX-1 and P1NP in ten individuals with type 1 diabetes and ten healthy controls matched for age, gender and body mass index (BMI) during fasting and euglycemic conditions. Each participant will receive double-blinded infusions of pramlintide (3 pmol/kg/min) and saline on two separate study days performed in randomised order.

The primary endpoints are the relative changes in the plasma levels of P1NP and 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 and P1NP as well as %-changes from baseline including nadir.

The secondary endpoints encompass changes in plasma concentrations of calcium, parathyroid hormone (PTH), alkaline phosphatase, osteocalcin, glucagon, insulin, C-peptide, glucose, glucose-dependent insulinotropic polypeptide and glucagon-like peptide 1 and glucagon-like peptide 2.

Study Timeline

• Study First Submitted: 2023-12-15
• Study First Submitted QC: 2023-12-15
• Study First Posted: 2023-12-29
• Status Verified: 2024-02
• Study Start: 2024-02-12
• Last Update Submitted: 2024-02-16
• Last Update Posted: 2024-02-21
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Pramlintide infusion	Pramlintide	A stable amylin analogue.
Placebo infusion	Placebo (saline) infusion	Isotonic saline (0.9% NaCl).

Primary Outcome Measures

Name	Time	Method
Relative changes in the plasma levels of N-terminal propeptide of type I procollagen (P1NP)	From -15 minutes to 180 minutes	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.
Relative changes in the plasma levels of C-terminal telopeptide of type I collagen (CTX-1)	From -15 minutes to 180 minutes	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.

Secondary Outcome Measures

Name	Time	Method
Changes in plasma concentrations of C-peptide.	From -15 minutes to 180 minutes	The changes in plasma concentrations will be assessed by the total and incremental (baseline-subtracted) area under the curve for plasma levels as well as %-changes from baseline including nadir.
Changes in plasma concentrations of glucagon.	From -15 minutes to 180 minutes	The changes in plasma concentrations will be assessed by the total and incremental (baseline-subtracted) area under the curve for plasma levels as well as %-changes from baseline including nadir.
Changes in plasma concentrations of insulin.	From -15 minutes to 180 minutes	The changes in plasma concentrations will be assessed by the total and incremental (baseline-subtracted) area under the curve for plasma levels as well as %-changes from baseline including nadir.
Changes in plasma concentrations of glucose-dependent insulinotropic polypeptide (GIP).	From -15 minutes to 180 minutes	The changes in plasma concentrations will be assessed by the total and incremental (baseline-subtracted) area under the curve for plasma levels as well as %-changes from baseline including nadir.
Changes in plasma concentrations of calcium.	From -15 minutes to 180 minutes	The changes in plasma concentrations will be assessed by the total and incremental (baseline-subtracted) area under the curve for plasma levels as well as %-changes from baseline including nadir.
Changes in plasma concentrations of glucose.	From -15 minutes to 180 minutes	The changes in plasma concentrations will be assessed by the total and incremental (baseline-subtracted) area under the curve for plasma levels as well as %-changes from baseline including nadir.
Changes in plasma concentrations of glucagon-like peptide 1 (GLP-1).	From -15 minutes to 180 minutes	The changes in plasma concentrations will be assessed by the total and incremental (baseline-subtracted) area under the curve for plasma levels as well as %-changes from baseline including nadir.
Changes in plasma concentrations of glucagon-like peptide 2 (GLP-2).	From -15 minutes to 180 minutes	The changes in plasma concentrations will be assessed by the total and incremental (baseline-subtracted) area under the curve for plasma levels as well as %-changes from baseline including nadir.
Changes in plasma concentrations of parathyroid hormone (PTH)	From -15 minutes to 180 minutes	The changes in plasma concentrations will be assessed by the total and incremental (baseline-subtracted) area under the curve for plasma levels as well as %-changes from baseline including nadir.
Changes in plasma concentrations of alkaline phosphatase	From -15 minutes to 180 minutes	The changes in plasma concentrations will be assessed by the total and incremental (baseline-subtracted) area under the curve for plasma levels as well as %-changes from baseline including nadir.
Changes in plasma concentrations of osteocalcin	From -15 minutes to 180 minutes	The changes in plasma concentrations will be assessed by the total and incremental (baseline-subtracted) area under the curve for plasma levels as well as %-changes from baseline including nadir.

Trial Locations

Locations (1)

Center for Clinical Metabolic Research, Gentofte Hospital; 🇩🇰 Hellerup, Capital Region, Denmark