Fasting Therapy for type 2 Diabetes Mellitus Patients.

"Long term impact of prolonged fasting on the vitamin D levels, serum calcium, glycemic control insulin resistance, anthropometric measures, quality of life, and disease perception among type 2 diabetes mellitus patients. A randomized control trial." - FAVIT Trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/03/050400

Enrollment

170

Registered

2023-03-06

Start date

Unknown

Completion date

Unknown

Last updated

2023-04-03

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

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Medically Supervised Fasting: Fasting for 10-days, which includes, three phases preparatory phase(day 1,day 2and day 3), fasting phase(day 4 to day 7) and re-feeding phase (day7 to day1

Eligibility

Inclusion criteria

Inclusion criteria: A diagnosis of type 2 diabetes mellitus Body Mass Index >= 25 Most recent HbA1C values > 6.0% and Treatment with oral anti-diabetic drugs

Exclusion criteria

Exclusion criteria: Patients under insulin Any recent history ( Any past history of syncope with calorie restriction Known case of severe kidney, heart, haematological or liver diseases Autoimmune diseases or patients who are on immunosuppressive drugs Pregnant women and lactating mothers Patients who are a part of any other diet modification or lifestyle programs. Patients who are a part of any other clinical trial

Design outcomes

Primary

Measure	Time frame
Serum Vitamin D (Total 25-hydroxy Vitamin D)Timepoint: Baseline, after 10 days of fasting, after fasting each month for consecutive 3 months. to see the sustainibility lab test will be done each month for another 2 months.	—

Secondary

Measure	Time frame
Brief illness perception scaleTimepoint: Baseline, after 10 days of fasting, after fasting each month for consecutive 3 months. to see the sustainibility lab test will be done each month for another 2 months.;Complete blood countTimepoint: Baseline, after 10 days of fasting, after fasting each month for consecutive 3 months. to see the sustainibility lab test will be done each month for another 2 months.;Fasting blood sugarTimepoint: Baseline, after 10 days of fasting, after fasting each month for consecutive 3 months. to see the sustainibility lab test will be done each month for another 2 months.;Fasting insulinTimepoint: Baseline, after 10 days of fasting, after fasting each month for consecutive 3 months. to see the sustainibility lab test will be done each month for another 2 months.;Glycated HemoglobinTimepoint: Baseline, after 10 days of fasting, after fasting each month for consecutive 3 months. to see the sustainibility lab test will be done each month for another 2 months.;Total serum CalciumTimepoint: Baseline, after 10 days of fasting, after fasting each month for consecutive 3 months. to see the sustainability lab test will be done each month for another 2 months.;WHO BREF quality of life questionnaireTimepoint: Baseline, after 10 days of fasting, after fasting each month for consecutive 3 months. to see the sustainibility lab test will be done each month for another 2 months.	—

Measure

Time frame

Brief illness perception scaleTimepoint: Baseline, after 10 days of fasting, after fasting each month for consecutive 3 months. to see the sustainibility lab test will be done each month for another 2 months.;Complete blood countTimepoint: Baseline, after 10 days of fasting, after fasting each month for consecutive 3 months. to see the sustainibility lab test will be done each month for another 2 months.;Fasting blood sugarTimepoint: Baseline, after 10 days of fasting, after fasting each month for consecutive 3 months. to see the sustainibility lab test will be done each month for another 2 months.;Fasting insulinTimepoint: Baseline, after 10 days of fasting, after fasting each month for consecutive 3 months. to see the sustainibility lab test will be done each month for another 2 months.;Glycated HemoglobinTimepoint: Baseline, after 10 days of fasting, after fasting each month for consecutive 3 months. to see the sustainibility lab test will be done each month for another 2 months.;Total serum CalciumTimepoint: Baseline, after 10 days of fasting, after fasting each month for consecutive 3 months. to see the sustainability lab test will be done each month for another 2 months.;WHO BREF quality of life questionnaireTimepoint: Baseline, after 10 days of fasting, after fasting each month for consecutive 3 months. to see the sustainibility lab test will be done each month for another 2 months.

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Countries

India

Contacts

Public ContactPradeep MK Nair

Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for Women, Bhopal

drpradeep18bnys@gmail.com9823262179

Outcome results

None listed

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