Targeting the secondary bile acid glycodeoxycholic acid as therapeutic strategy in type 2 diabetes mellitus.
- Conditions
- type 2 diabetes mellitus10018424
- Registration Number
- NL-OMON55800
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
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 a BMI between 25 and 30 kg/m2 and waist
circumference 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
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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary objective of phase 1 is to determine safety of long-term gDCA<br /><br>administration in healthy volunteers.<br /><br><br /><br>The overall primary objective of the TRADE study is:<br /><br><br /><br>To assess the effect of gDCA and enteric-coated gDCA treatment as TGR5 and VDR<br /><br>activators on:<br /><br><br /><br>- Postprandial GLP-1 and insulin secretion<br /><br>- Postprandial inflammatory responses<br /><br>- Postprandial plasma lipid levels </p><br>
- Secondary Outcome Measures
Name Time Method