To Study the effect of Low Carbohydrate High Fat (LCHF) diet and Pharmacotherapy (Metformin And Sitagliptin)in progression of prediabetes

Phase 4

• Conditions: Health Condition 1: E08- Diabetes mellitus due to underlying condition

• Registration Number: CTRI/2020/11/029352
• Lead Sponsor: Siddhartha Medical college and Government General hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Pre-diabetic patients (FPG ï?  110-125mg/dL, IGT ï?  140-200mg/dL, HbA1c -5.7 to 6.4%)

- Age > 25 yr

- Over weight or obese patients with BMI > 25kg/m2

- Those with strong family history(first degree relative with diabetes) and associated factors of diabetes

- Pre-diabetics patients with hypertension (B.P. >140/90 mm Hg).

- PCOS (Polycystic ovary syndrome)

- Subjects with Life Style modifications (balanced diet, include a physical activity at least 150min/week, maintain regular & adequate sleep, no smoking and alcohol) are included.

Exclusion Criteria

- Age > 60years

- Diabetic patients (HbA1c > 6.5%, FPG >125mg/dL).

- Type - I diabetes patients.

- Gestational diabetic patients.

- Known endocrine diseases (Hypo/hyperthyroidism, Cushingâ??s syndrome).

- Patients on diabetogenic drugs (Corticosteroids, Antibiotics (Fluoroquinolones), β-blockers, Thiazide and Thiazide-Like Diuretics, 2nd Generation Antipsychotics, Calcineurin Inhibitors (CNIs),Protease Inhibitors etc.,

- Patients taking drugs which produce hypertension (Glucocorticoids, testosterone, ethyl estradiol, adrenergic agents, ergot alkaloids, MAO inhibitors, NSAID, Cyclosporine, Bromocriptine, alcohol, etc.,)

- Patients with HIV, Tuberculosis and other chronic infectious diseases.

- Patients on anti-obesity drugs.

- Patients with known cardiac renal, hepatic conditions, respiratory failure and psychological disorders.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression of Prediabetic patient to diabeticTimepoint: Every 3 months basic parameters are estimated till 3 years

Secondary Outcome Measures

Name	Time	Method
Effectiveness of diet and drugs in prediabetes and other parameters like weight, lipid profile, blood urea, serum creatinine etc.,Timepoint: Every 3months basic parameters are estimated till 3 years.