type 2 diabetes
Conditions
Interventions
Trade Name: Pheburane
Product Name: Pheburane
Product Code: NaPB
Pharmaceutical Form: Granules in single-dose container
Pharmaceutical form of the placebo: Granules
Route of administration of the plac
Sponsors
Maastricht University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Patients are able to provide signed and dated written informed consent prior to any study specific procedures 2. Women are post-menopausal (defined as at least 1 year post cessation of menses) and aged = 45 and = 70 years. Males are aged = 40 years and = 70 years 3. Patients should have suitable veins for cannulation or repeated venipuncture 4. Caucasians 5. BMI: 28-38 kg/m2 6. Diagnosed with T2D at least 1.5 years before the start of the study 7. Relatively well-controlled T2D: HbA1c =65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: 1. Previous enrolment in a clinical study with an investigational product during the last 3 months or as judged by the Investigator 2. Participate in physical activity more than 3 times a week 3. Unstable body weight (weight gain or loss > 5 kg in the last three months) 4. Insulin dependent T2D 5. Patients with congestive heart failure and and/or severe renal and or liver insufficiency or known sodium retention with oedema 6. Patients using Probalan (probenecid), Haldol (haloperidol), Depakene (valproate) or medical products containing corticosteroids 7. Smoking 8. Men: Hb <8.4 mmol/L, Women: Hb <7.8 mmol/l A medical doctor will judge participation eligibility based on the medical history questionnaire, medication use and fasting blood parameters. If the medical doctor advises that a patient cannot participate, the patient will be excluded from enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective is the delta change in whole body insulin sensitivity expressed as glucose disposal rate (µmol/kg/min) upon 2 weeks of Na-PB vs. placebo treatment. ;Secondary Objective: Secondary objectives are muscle mitochondrial oxidative capacity (pmol/mg/s), muscle and liver fat content (%), leucine oxidation rate (µmol/kg/min) and energy metabolism (respiratory exchange ratio and kJ/kg/min). ;Primary end point(s): The endpoint of study is the measurement of insulin sensitivity of the 16th participant after the second intervention period. ;Timepoint(s) of evaluation of this end point: after finalising the second intervention period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The second endpoints of study are the measurements of mitochondrial function, energy metabolism, leucine oxidation, muscle and liver fat of the 16th participant ;Timepoint(s) of evaluation of this end point: after the second intervention period. | — |
Countries
Netherlands
Contacts
Public ContactClinical trials.gov
Maastricht University
Outcome results
None listed