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

A study of life style modification with and without metformin in prediabetic subjects

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/09/009635

Enrollment

Registered

2017-09-05

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E139- Other specified diabetes mellituswithout complications Health Condition 2: null- prediabetes

Interventions

Intervention1: Tab Metformin250mg twice daily: tablet Metformin 250 mg twice daily will be given along with life style modification Control Intervention1: life style modification: These participants w

Eligibility

Inclusion criteria

Inclusion criteria: body mass index 18.5-29.9Kg/m2 Non diabetic individuals with either impaired fasting glucose (FBS >100mg/dl 140 <200mg/dl), Hb A1c 5.7% -6.4%

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
At the end of 1 year the patient will be categorized as mentioned below based on the findings. Normal â?? FBS 100mg/dl, 2hr glucose PPBS140mg/dl and HbA1c 5.6% Prediabetic- FBS 100mg/dl 126mg/dl) or 2hr glucose PPBS 140 200mg/dl or HbA1c 5.7% -6.4% Diabetic â??FBS126mg/dl or 2hr glucose PPBS 200mg/dl and HbA1c 6.5% Timepoint: At the end of 1 year the patient will be categorized as mentioned below based on the findings. Normal â?? FBS 100mg/dl, 2hr glucose PPBS140mg/dl and HbA1c 5.6% Prediabetic- FBS 100mg/dl 126mg/dl) or 2hr glucose PPBS 140 200mg/dl or HbA1c 5.7% -6.4% Diabetic â??FBS126mg/dl or 2hr glucose PPBS 200mg/dl and HbA1c 6.5% Recruitment has started in the month of september 2016 and follow up is after 3 months , 6 months and 1 year	—

Measure

Time frame

At the end of 1 year the patient will be categorized as mentioned below based on the findings. Normal â?? FBS 100mg/dl, 2hr glucose PPBS140mg/dl and HbA1c 5.6% Prediabetic- FBS 100mg/dl 126mg/dl) or 2hr glucose PPBS 140 200mg/dl or HbA1c 5.7% -6.4% Diabetic â??FBS126mg/dl or 2hr glucose PPBS 200mg/dl and HbA1c 6.5% Timepoint: At the end of 1 year the patient will be categorized as mentioned below based on the findings. Normal â?? FBS 100mg/dl, 2hr glucose PPBS140mg/dl and HbA1c 5.6% Prediabetic- FBS 100mg/dl 126mg/dl) or 2hr glucose PPBS 140 200mg/dl or HbA1c 5.7% -6.4% Diabetic â??FBS126mg/dl or 2hr glucose PPBS 200mg/dl and HbA1c 6.5% Recruitment has started in the month of september 2016 and follow up is after 3 months , 6 months and 1 year

—

Secondary

Measure	Time frame
antioxidants in prediabetic subjectsTimepoint: one year	—

Countries

India

Contacts

Public ContactDr Asha B

Sri Devaraj Urs Medical College

dr.ashareddy@gmail.com9686071177

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026