A study on the effect of intermittent fasting in reducing the blood sugar level and number of medicines in type 2 diabetic patients.
- Conditions
- Type 2 diabetes mellitus without complications,
- Registration Number
- CTRI/2023/09/057784
- Lead Sponsor
- Jawaharlal Nehru Medical College
- Brief Summary
Diabetes mellitus is a chronic disease characterized by elevated levels of blood glucose (hyperglycemia) resulting from defects in insulin secretion, insulin action or both. It is a significant public health problem worldwide, with an estimated 463 million adults aged between 20-79 years with diabetes in 2019. Previous research has proposed he correlation between the circadian rhythm and metabolic homeostasis, during a 24 h period it is the circadian rhythm that keeps a balance between the anabolic and catabolic activities. The fed-fast cyclical rhythm maintains a balance between mRNA and proteins which in turn is responsible for glycolysis, protein synthesis, lipid synthesis and oxidation, gluconeogenesis and mitochondrial activities. Time restricted feeding has also been proven to reduce the incidence of glucose intolerance, fatty liver and dyslipidemia. Informed consent will be obtained from the participants fulfilling the inclusion criteria. Baseline characteristics of the patients will be recorded. The overall duration of the study will be for 12 weeks, and the patient will be asked to come for follow up at the end of 4th, 8th, and 12th week. The participants will be informed to keep a sugar pill or sweets with them at all time and to take it if he or she experiences symptoms of hypoglycemia which includes: sweating, trembling, palpitations, extreme hunger, dizziness, headache. Those experiencing symptoms will be evaluated either in person or via teleconsultation and appropriate reduction in the drugs will be made. In the event that the participant doesn’t experience symptoms of hypoglycemia, the dose adjustment will be done based on lab investigations during follow up. The participants will also be requested to consume light dinner. The participants, in the fasting group will be permitted to consume food between the hours of 7 AM to 3 PM (7 hours) with breakfast and lunch preferably at 7 AM and 2 PM respectively. The participants will be requested to observe a period of fasting from 3 PM till 7 AM (16 hours). Participants will be encouraged to consume salads during the fasting hours in the event that they become too hungry.
Both the study group and the control group will be given the same advice with respect to diet and exercise. The data will be recorded in MS Excel and presented as mean ± SEM. The parametric data will be analyzed using ANCOVA using baseline data as covariate control. Non parametric data will be analyzed using chi square test. The analysis and graphical representation will be done using IBM- SPSS 23 and “R†statistical package.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 60
- 1.Patients of either gender and between the age of 18-75 years 2.Confirm cases of Type 2 Diabetes mellitus with HbA1c > 8.0 taking ≥ 2 anti-diabetic medication 3.Willing to perform intermittent fasting as per instructions.
- 4.Willing to give informed consent.
1.Pregnant or lactating females 2.Patients having history of any major cardiovascular or neurovascular event in past like CVA/Stroke 3.Patients with significant active liver or kidney diseases 4.Patients with history of any endocrinal diseases 5.Patients on chronic medication which are known to affect the glycemic status of the patient.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the effect of intermittent fasting on glycemic control in patients with type II diabetes mellites on polypharmacy over a period of 12 weeks The overall duration of the study will be for 12 weeks, and the patient will be asked to come for follow up at the end of 4th, 8th, and 12th week.
- Secondary Outcome Measures
Name Time Method 1.To assess the effect of intermittent fasting on glycemic control in pre-diabetic patients over a period of 12 weeks 2.To determine the post intermittent fasting reduction in medication in patients of diabetes mellitus on polypharmacy prescription.
Trial Locations
- Locations (1)
Jawaharlal Nehru Medical College and Hospital
🇮🇳Aligarh, UTTAR PRADESH, India
Jawaharlal Nehru Medical College and Hospital🇮🇳Aligarh, UTTAR PRADESH, IndiaDr Syed Shariq NaeemPrincipal investigator9634912166syedshariq1@gmail.com