Effect of high dose vitamin B1 on early stage kidney disease in type 2 diabetes
Phase 1
- Registration Number
- CTRI/2008/091/000112
- Lead Sponsor
- Sheikh Zayed Hospital Lahore Pakistan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Applicable
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
Age 35-65 years old,
Patients with type 2 diabetes and microalbuminuria (albumin excretion rate (AER) 30 - 299 mg/24 h),
Diabetes duration of 5 years or more,
Glycated haemoglobin HbA1c ≤12.5%,
Body mass index (BMI) 19 - 40 kg/m2.
Exclusion Criteria
Allergy or intolerance to thiamine,
Participation in another clinical study within the last 30 days,
Women who are pregnant or breast feeding,
Women of child bearing potential not using adequate contraceptive precautions,
End stage renal disease (creatinine > 2mg/dl),
Liver diseases (ASTP >3xULN, serum albumin <3.4 g/dl, acute hepatitis), and
Any other significant morbidity.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method rinary excertion of albumin (24 h collection)Timepoint: Baseline; after 1, 2 and 3 months therapy; and after 1 and 2 months washout.
- Secondary Outcome Measures
Name Time Method Plasma cholesterol and triglyceridesTimepoint: Baseline; after 1, 2 and 3 months therapy; and after 1 and 2 months washout.