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to know the effect of diet/ exercise and metformin in patients with boarderline high sugar levels

Phase 4
Completed
Conditions
Health Condition 1: E139- Other specified diabetes mellituswithout complicationsHealth Condition 2: null- prediabetes
Registration Number
CTRI/2017/09/009635
Lead Sponsor
Sri Devaraj Urs Academy of Higher Education and Research
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
105
Inclusion Criteria

body mass index 18.5-29.9Kg/m2

Non diabetic individuals with either impaired fasting glucose (FBS >100mg/dl < 126mg/dl), impaired glucose tolerance (2hr glucose PPBS >140 <200mg/dl), Hb A1c 5.7% -6.4%

Exclusion Criteria

1.Diabetic patients Type 1 and 2 (FBS >126mg/dl, PPBS >200mg/dl and HbA1c >6.5%)

2.Patients with contraindications to Metformin (CCF, hepatic dysfunction, renal impairment) and hypersensitivity

3.Pregnant and lactating women

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
At the end of 1 year the patient will be categorized as mentioned below based on the findings. <br/ ><br>Normal â?? FBS 100mg/dl, 2hr glucose PPBS140mg/dl and HbA1c 5.6% <br/ ><br>Prediabetic- FBS 100mg/dl 126mg/dl) or 2hr glucose PPBS 140 200mg/dl <br/ ><br>or HbA1c 5.7% -6.4% <br/ ><br>Diabetic â??FBS126mg/dl or 2hr glucose PPBS 200mg/dl and HbA1c 6.5% <br/ ><br>Timepoint: At the end of 1 year the patient will be categorized as mentioned below based on the findings. <br/ ><br>Normal â?? FBS 100mg/dl, 2hr glucose PPBS140mg/dl and HbA1c 5.6% <br/ ><br>Prediabetic- FBS 100mg/dl 126mg/dl) or 2hr glucose PPBS 140 200mg/dl <br/ ><br>or HbA1c 5.7% -6.4% <br/ ><br>Diabetic â??FBS126mg/dl or 2hr glucose PPBS 200mg/dl and HbA1c 6.5% <br/ ><br>Recruitment has started in the month of september 2016 and follow up is after 3 months , 6 months and 1 year <br/ ><br>
Secondary Outcome Measures
NameTimeMethod
antioxidants in prediabetic subjectsTimepoint: one year
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