The effect of the secondary bile acid glycodeoxycholic acid as a therapy for diabetes.

Phase 1

• Conditions: Type 2 diabetes mellitus; MedDRA version: 20.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2017-002079-24-NL
• Lead Sponsor: Academic Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-26
• Last Update Posted: 5 June 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Ability to provide informed consent
- Age: 18 years or older at the time of signing the informed consent
- Male

Specific inclusion criteria for the healthy lean subject group:
- BMI between 18,5-25 kg/m2 or BMI between 25 and 30 kg/m2 with a waist circumference between between 79 cm and 94 cm
- HOMA-IR index: = 2.0 (measured as fasting insulin (pmol/L) x fasting glucose (mmol/L)) / 135)

Specific inclusion criteria for the type 2 diabetes mellitus (T2D) patient group:
- T2D treated with diet and/or medication only (medication not changed in the past 3 months)
- HbA1c 53-64 mmol/mol
- BMI above 25 kg/m2

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Use of medication that interferes with bile acid metabolism (colesevelam, colestimide, ursodeoxycholic acid).
- Diabetes treatment with dipeptidyl peptidase-4 inhibitors, GLP-1 receptor agonists or insulin
- Hypercholesterolemia treatment with statins or fibrates unless on a stable dose for at least 3 months prior to screening
- Use of nicotinic acid or derivates of nicotinic acid within 4 weeks prior to screening
- Use of other drugs such as the following: vitamin K antagonists, ciclosporine, antacids containing aluminium hydroxide or aluminium oxide
- Cholecystectomy
- Gastro-intestinal disorders, including gallstone disease
- Nefropathy checked by blood chemistry (creatinine, eGFR)
- Liver disease checked by blood chemistry (ASAT, ALAT, GGT, AF, bilirubin)
- Weight increase or decrease >10% in previous 3 months
- Alcohol use >3 units/day
- Tobacco use
- XTC, cannabis, cocaine or opioids abuse
- Likely to leave the study before its completion
- Participation in other intervention studies

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified