Insulin Resistance Clinical Trial
— TAF-IROfficial title:
Changes in Insulin Sensitivity in Healthy Volunteers Taking Tenofovir Alafenamide (TAF)-Containing Antiretroviral Medication: The TAF-IR Study
Verified date | August 2017 |
Source | Technische Universität München |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Investigation of possible changes in insulin sensitivity in healthy volunteers taking the following HIV treatment combinations: F/TAF (group 1) as compared to E/C/F/TAF (group 2) as compared to R/F/TAF (group 3). The measurement of insulin sensitivity will be performed in 30 HIV-negative healthy non-obese (BMI 18-25) male volunteers before and after 14±2 days of treatment. The volunteers will be randomly assigned to one of the three groups. Changes in insulin sensitivity will be measured by golden standard hyperinsulinemic euglycemic clamp (HEGC) technique, using glucose and insulin infusion as diagnostic agents
Status | Completed |
Enrollment | 30 |
Est. completion date | July 28, 2017 |
Est. primary completion date | July 28, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - Male, healthy volunteers, age range =18-40 years - Written informed consent and willingness to attend study visits - Willingness for taking study medication during study period - Birth control during study period Exclusion Criteria: - Participation in other interventional clinical trials and/or participation in another clinical trial with medicinal products within the last 4 weeks - Known allergies or contraindications against study medication - Known metabolic dysfunction, e.g. Hypertriglyceridemia or Diabetes mellitus - Smoking or alcohol abuse (> 15g/day alcohol consumption) - Documented HIV-infection - BMI <18 >25 - Recurrent medication or any antiretroviral medication within the last 30 days - ALT, AST, Bilirubin, Creatinine, TSH, blood pressure, heart rate, QTc are out of normal range o Normal ranges for clinical chemistry are defined by local laboratory. For blood pressure normal range is defined as 100/60-140/90; for heart rate 60-100 - Known liver, kidney, heart, pulmonary, gastrointestinal, endocrinological, rheumathoid, neurological, psychiatric or metabolic diseases - Any situation of which the sponsors sees relevant contraindication against study participation - Imprisoned or situated people |
Country | Name | City | State |
---|---|---|---|
Germany | Klinikum rechts der Isar (IZAR) | Munich |
Lead Sponsor | Collaborator |
---|---|
Technische Universität München |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in insulin sensitivity | To assess changes in insulin sensitivity (mean glucose disposal rate normalized to body weight (MBW [mg glucose/min*kg]) in HIV-negative, healthy, non-obese (BMI 18-25) male volunteers following 14±2 days of treatment with group 1 or group 2 or group 3, as measured by HEGC. | 14±2 days | |
Secondary | changes in insulin sensitivity | To asses changes in insulin sensitivity as measured by mean glucose disposal rate normalized to body weight and steady-state insulin concentration (MBW/L [mg glucose/min kg UIU]) and normalized to body weight and steady-state glucose concentration (MCR [dL/min kg]), HOMA-IR, HOMA-, QUICKI and 1/QUICKI indices in HIV-negative, healthy, non-obese male volunteers following 14 +/-2 days of administration of IMP in group 1, 2 or 3. | 14 +/-2 days | |
Secondary | lipid metabolism | Changes in lipid metabolism in HIV-negative, healthy, non-obese male volunteers following 14±2 days of administration of IMP in group 1, 2 or 3. | 14±2 days |
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