| CTRI Number |
CTRI/2023/09/057784 [Registered on: 18/09/2023] Trial Registered Prospectively |
| Last Modified On: |
16/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Intermittent fasting] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study on the effect of intermittent fasting in reducing the blood sugar level and number of medicines in type 2 diabetic patients. |
|
Scientific Title of Study
|
Open label randomized controlled trial evaluating the effect of three months intermittent fasting on polypharmacy in patients with type II diabetes mellitus.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Syed Shariq Naeem |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Nehru Medical College, Aligarh Muslim University. |
| Address |
Department of Pharmacology
Jawaharlal Nehru Medical College, Aligarh Muslim University.
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
9634912166 |
| Fax |
|
| Email |
syedshariq1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Syed Shariq Naeem |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Nehru Medical College, Aligarh Muslim University. |
| Address |
Department of Pharmacology
Jawaharlal Nehru Medical College, Aligarh Muslim University.
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
9634912166 |
| Fax |
|
| Email |
syedshariq1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Syed Shariq Naeem |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Nehru Medical College, Aligarh Muslim University. |
| Address |
Department of Pharmacology
Jawaharlal Nehru Medical College, Aligarh Muslim University.
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
9634912166 |
| Fax |
|
| Email |
syedshariq1@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College |
| Address |
Aligarh Muslim University, Aligarh. |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Syed Shariq Naeem |
Jawaharlal Nehru Medical College and Hospital |
OPD 20, Rajiv Gandhi Centre for Diabetes and Endocrinology , Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University.202002
Aligarh
UTTAR PRADESH |
9634912166
syedshariq1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Jawaharlal Nehru Medical College and Hospital, Faculty of Medicine, AMU. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intermittent Fasting with standard of care |
12 weeks
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).
Standard of Care includes Primary or Adjutant Diabetic medication with diet planning and exercise |
| Comparator Agent |
Standard of Care (with no intermittent fasting) |
12 weeks, Standard of Care includes Primary or Adjutant Diabetic medication with diet planning and exercise |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
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.
3. To assess the effect of intermittent fasting on biochemical parameters in pre-diabetic patients over a period of 12 weeks
4. To assess the adverse reaction in patients of diabetes mellitus undergoing intermittent fasting over a period of 12 weeks
|
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/09/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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.
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