Health Condition 1: R730- Abnormal glucose
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Apparently healthy individuals aged greater 30 years of either gender with HbA1c between 5.7 and 6.4
Exclusion criteria
Exclusion criteria: 1. BMI greater than 40 kg per m2 2. Those on drugs known to increase blood glucose levels like steroids, oral contraceptive pills etc and on herbal or other alternative system of medication. 3. Impaired liver function (AST or ALT elevated greater 2 times normal) 4. Renal insufficiency (GFR less than 60 ml per min) 5. Pregnant women and lactating mothers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Curcuma longa and metformin alone and in combination as compared to placebo on modifying HbA1c level in prediabetes population at the end of 12 weeksTimepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 4. To evaluate the safety of Curcuma longa and metformin alone and in combination as compared to placebo in prediabetes population over a period of 24 weeksTimepoint: 24 weeks;To evaluate the effect of Curcuma longa and metformin alone and in combination as compared to placebo on exercise capacity in prediabetes population at the end of 12 weeks and 24 weeksTimepoint: 12 weeks and 24 weeks;To evaluate the effect of Curcuma longa and metformin alone and in combination as compared to placebo on vascular functions (carotid femoral Pulse Wave Velocity, brachial ankle pulse wave velocity, right and left brachial arterial stiffness index, right and left arterial stiffness index, ankle brachial index, aortic systolic/diastolic pressure, aortic augmentation pressure and aortic augmentation index) as compared to placebo in prediabetes population at the end of 12 weeks and 24 weeksTimepoint: 12 weeks and 24 weeks;To evaluate the efficacy of Curcuma longa and metformin alone and in combination as compared to placebo on glycemic status and insulin resistance in prediabetes population at the end of 12 weeks and 24 weeksTimepoint: 12 weeks and 24 weeks | — |
Countries
India
Contacts
JIPMER, Puducherry