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

Evaluation of Progression of Prediabetes with Low Carbohydrate High Fat (LCHF) diet and Pharmacotherapy (Metformin and Sitagliptin).

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/11/029352

Enrollment

150

Registered

2020-11-25

Start date

Unknown

Completion date

Unknown

Last updated

2022-11-21

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

Conditions

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

Interventions

Intervention1: Low Carbohydrate High Fat (LCHF) Diet: This group of subjects are given a diet plan by counseling. In their diet we reduce the carbohydrate intake and increasing the healthy fats. (For

Eligibility

Inclusion criteria

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

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), Î²-blockers, Thiazide and Thiazide-Like Diuretics, 2nd GenerationÂ 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.

Design outcomes

Primary

Measure	Time frame
Progression of Prediabetic patient to diabeticTimepoint: Every 3 months basic parameters are estimated till 3 years	—

Secondary

Measure	Time frame
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.	—

Countries

India

Contacts

Public ContactLakshmi Deepika

Dr. NTR University, Siddhartha Medical College, Vijayawada

kurli.sankar@yahoo.com9440673953

Outcome results

None listed

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