Glucose-Dependent Insulinotropic Polypeptide - Effects on Markers of Bone Turnover in Patients With Type 1 Diabetes

What Was Tested

The trial (not phased) is built around GIP (Gastric Inhibitory Polypeptide).

Investigate GIP effects on biomarkers involved in bone homeostasis.

It had five arms (groups): Hypoglycemia-saline (placebo comparator), Hypoglycemia-GIP (experimental), Hypoglycemia-GLP-1 (active comparator), Hyperglycemia-GIP (experimental) and Hyperglycemia-Saline (placebo comparator).

The registry classes the interventions as other.

Who Took Part

Enrollment: 10 actual participants took part.

It was open to men only aged from 18 years up to 50 years.

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

Examples of who could join: Patients with type 1 diabetes (positive islet cell/ glutamic acid decarboxylase-65 antibodies).

The full record lists 2 inclusion and 5 exclusion criteria; among the exclusions: standard plasma biochemical measurements outside normal reference interval (alanine aminotransferase, bilirubin, thyroid-stimulating hormone, hemoglobin, creatinine, and spot urine albumin-creatinine ratio);; an abnormal state of hypoglycemia awareness,; treatment with medication (besides insulin) that could not be paused for 12 hours up to and during the days of the experiments.

How the Study Was Run

The set-up was randomized, crossover and triple-blind.

The participants were allocated by chance, so the GIP (Gastric Inhibitory Polypeptide) group and the comparison group should start out alike.

Each person switched between GIP (Gastric Inhibitory Polypeptide) and the comparison at some point, usually with a gap in between.

Blinding on both sides kept the participants and researchers unaware of who received GIP (Gastric Inhibitory Polypeptide).

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2012-11-17 with completion listed for 2016-12-01.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: C-terminal telopeptide of type I collagen (CTX) (time frame: 30 minutes intervals, time 0 up to 120 min).

It also tracked 2 secondary outcomes, for example Parathyroid hormone (PTH) and N-terminal propeptide of type 1 procollagen (P1NP).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of GIP (Gastric Inhibitory Polypeptide) in 10 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the GIP (Gastric Inhibitory Polypeptide) compound page, all human trials.