The Role of Amylin in Bone Metabolism

What Was Tested

The trial (not phased) is built around Amylin (Islet Amyloid Polypeptide).

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.

It had two arms (groups): Pramlintide infusion (experimental) and Placebo infusion (placebo comparator).

A stable amylin analogue.

The registry classes the interventions as other.

More on the Plan

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.

Who Took Part

The registry lists 20 planned participants were the target.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Age between 18 and 60 years. BMI between 18.5 and 27 kg/m2. Type 1 diabetes duration of 2-20 years. Treatment with a stable basal-bolus or insulin pump regimen for ≥3 months.

The full record lists 9 inclusion and 27 exclusion criteria; among the exclusions: anaemia (haemoglobin below normal range); liver disease (alat and/or asat \>2 times normal values) or history of hepatobiliary disorder; microvascular complications except non-proliferative retinopathy.

How the Study Was Run

Design: randomized, crossover and double-blind.

The participants were allocated by chance, so the Amylin (Islet Amyloid Polypeptide) group and the comparison group should start out alike.

Each person switched between Amylin (Islet Amyloid Polypeptide) and the comparison at some point, usually with a gap in between.

As a double-blind Amylin (Islet Amyloid Polypeptide) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2024-02-12 with completion listed for 2024-08-01.

It ran at 1 site in Denmark.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Relative changes in the plasma levels of C-terminal telopeptide of type I collagen (CTX-1) (time frame: From -15 minutes to 180 minutes). Relative changes in the plasma levels of N-terminal propeptide of type I procollagen (P1NP) (time frame: From -15 minutes to 180 minutes).

It also tracked 11 secondary outcomes, for example Changes in plasma concentrations of glucagon, Changes in plasma concentrations of insulin, Changes in plasma concentrations of C-peptide, Changes in plasma concentrations of glucose, Changes in plasma concentrations of glucose-dependent insulinotropic polypeptide (GIP) and Changes in plasma concentrations of glucagon-like peptide 1 (GLP-1).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Amylin (Islet Amyloid Polypeptide) in 20 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Amylin (Islet Amyloid Polypeptide) compound page, all human trials.