cardiometabolic risk obesity
Conditions
Interventions
Subjects will be treated with either TRC150094 tablets of 50 mg or placebo once
a day for 28 days.
Venapunction will be performed three times
All subjects will undergo a hyperinsulinemic euglycemic c
Sponsors
Torrent Pharmaceuticals Limited
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Adult male 2. Age range 30-65 years at screening 3. Caucasian or Indian Ethnicity 4. Waist circumference * 102 cm for Caucasians and * 90 cm for Indians at screening.27 5. Fasting Serum Insulin * 10 mU/ml at screening 6. Blood Pressure 130/85 mmHg at screening(or patients taking medication for hypertension) 7. Stable weight during 3 months prior to the study (assessed through medical history of the patient) 8. Drug naïve diabetic patients* or patients with impaired fasting glucose i.e > 100 mg/dl or 5.5 mmol/l and
Exclusion criteria
Exclusion criteria: 1. Medical history, physical examination, vital signs, clinical laboratory tests, 12-lead ECG and Chest X ray (in India only) with any significant abnormalities, in the opinion of the investigator. 2. Subjects with any known somatic illness 3. Subject currently using medication, which can influence glucose or FFA metabolism such as fibrates, niacin, ACE inhibitors, PPAR agonists, omega 3 fatty acids. 4. eGFR 15 cigarettes or equivalent per day).
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Early efficacy markers that will be explored include: * Hepatic fat * Lipid parameters * Metabolic markers | — |
Primary
| Measure | Time frame |
|---|---|
| Insulin Sensitivity: * Rate of Glucose Disposal * Suppression of Endogenous Glucose Production * Suppression of rate of lipolysis | — |
Countries
Netherlands
Outcome results
None listed