Randomized, double blind, placebo controlled, parallel group, proof of concept clinical trial on the effect of low does folic acid supplementation on selected biochemical markers associated with one carbon metabolism and redox amino thiol status in type 2 diabetes mellitus patients.
- Conditions
- Diabetes mellitus(Type 2)
- Registration Number
- SLCTR/2022/011
- Lead Sponsor
- Department of Medical Laboratory Science (MLS), Faculty of Allied Health sciences (FAHS), General Sir John Kotelawala Defence University (KDU)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- Not specified
Subject is a (male or female) between the age of 18 and 60 years.
- Subject is confirmed as a type 2 Diabetes Mellites without any T2DM related complications.
- Subjects who have been diagnosed with having T2DM during the past five (5) years.
- T2DM patients with CKD (1-4 stages) KDOQI criteria of chronic kidney disease diagnosis
- Kidney damage for >3 months, as defined by structural or functional abnormalities of the kidney, with or without decreased GFR, manifest by either:
(Pathological abnormalities; or Markers of kidney damage, including abnormalities in the composition of the blood or urine, or abnormalities in imaging tests)
- GFR < 60 mL /min /1.73m2 for >3 months, with or without kidney damage
- T2DM patients who are diagnosed with any kind of T2DM complications including Cerebro Vascular Disease, diabetic retinopathy, and neuropathy.
- T2DM Patients who are diagnosed with any other diseases (cancer, anemia, and diseases related to hormone disorders).
- T2DM patients who have been diagnosed with Diabetes over 5 years.
- Subjects who are already undergoing vitamin B12 / Folate supplementation or under any multivitamin which include vitamin B12 and folate.
- Pregnant women and Children.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method