The Role of Amylin in Bone Metabolism
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Filip Krag Knop
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Relative changes in the plasma levels of N-terminal propeptide of type I procollagen (P1NP)
Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Relative changes in the plasma levels of N-terminal propeptide of type I procollagen (P1NP)
Time Frame: 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)
Time Frame: 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 Outcomes
- Changes in plasma concentrations of C-peptide.(From -15 minutes to 180 minutes)
- 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 glucose-dependent insulinotropic polypeptide (GIP).(From -15 minutes to 180 minutes)
- Changes in plasma concentrations of calcium.(From -15 minutes to 180 minutes)
- Changes in plasma concentrations of glucose.(From -15 minutes to 180 minutes)
- Changes in plasma concentrations of glucagon-like peptide 1 (GLP-1).(From -15 minutes to 180 minutes)
- Changes in plasma concentrations of glucagon-like peptide 2 (GLP-2).(From -15 minutes to 180 minutes)
- Changes in plasma concentrations of parathyroid hormone (PTH)(From -15 minutes to 180 minutes)
- Changes in plasma concentrations of alkaline phosphatase(From -15 minutes to 180 minutes)
- Changes in plasma concentrations of osteocalcin(From -15 minutes to 180 minutes)
Investigators
Filip Krag Knop
Professor, MD, PhD
University Hospital, Gentofte, Copenhagen