Diabetes mellitus(Type 2)
Conditions
Interventions
1. Study setting: Diabetes clinics at Colombo South Teaching Hospital (CSTH ) Sri Lanka and University hospital-General Sir John Kotelawala Defence University ,Werahara, Si Lanka.
2. Randomization,
Sponsors
Department of Medical Laboratory Science (MLS), Faculty of Allied Health sciences (FAHS), General Sir John Kotelawala Defence University (KDU)
Department of Natural Sciences, Faculty of Engineering and Science, University of Agder (UiA), Norway
Eligibility
Inclusion criteria
Inclusion criteria: - 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.
Exclusion criteria
Exclusion criteria: - 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Percentage change (Change in selected biomarkers from baseline. (Homocysteine, cysteine, cysteinyglycine, methionine, Glutathione, SAM, and SAH). Percentage change = Change of plasma concentration of biomarker/plasma concentration of biomarker before folic acid supplementation [Assessment will be done just before the folic acid/placebo intervention (day 1) and just after the 100 days supplementation (day 101). ] | — |
Secondary
| Measure | Time frame |
|---|---|
| • Percentage changes in the glycemic levels (FBS and HBA1c levels) Percentage change = Change of plasma concentration of glycemic levels/glycemic levels before folic acid supplementation [Assessment will be done just before the folic acid/placebo intervention (day 1) and just after the 100 days supplementation.(day 101)] • Percentage changes in the lipid profile (LDL, HDL, Triglyceride, and total Cholesterol) Percentage change = Change of plasma concentration of lipid levels/lipid levels before folic acid supplementation [ ] [ ] [ ] [ ] [ ] [ ] [ ] | — |
Countries
Sri Lanka
Contacts
Public ContactRS Maddumage
Demonstrator
Outcome results
None listed