| CTRI Number |
CTRI/2023/04/051291 [Registered on: 05/04/2023] Trial Registered Prospectively |
| Last Modified On: |
03/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Modification of meals frequency to 2 meals only] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of frequency of meals on control of HbA1C in recently diagnosed type 2 diabetes mellitus patients |
|
Scientific Title of Study
|
An open label parallel design randomized control trial of type 2 diabetes management with two-meals a day and exercise against the conventional multi-meal and exercise approach for effect on HbA1c and anti-diabetic medication in six months in newly detected diabetic subjects in a tertiary care Institute in Maharashtra. |
| Trial Acronym |
RCT 2OMEX |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR AKHIL RAMESH PATIL |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SMBT Institute of Medical sciences and Research centre, Dhamangaon, Nashik |
| Address |
Department of Medicine,
SMBT IMS RC. Nandi hills.
Dhamangaon. Tal. Igatpuri. Nashik
Nashik
MAHARASHTRA
422403
India |
| Phone |
9921030140 |
| Fax |
|
| Email |
akhilpatil3713@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR AKHIL RAMESH PATIL |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SMBT Institute of Medical sciences and Research centre, Dhamangaon, Nashik |
| Address |
Department of Medicine,
SMBT IMS RC. Nandi hills.
Dhamangaon. Tal. Igatpuri. Nashik
Nashik
MAHARASHTRA
422403
India |
| Phone |
9921030140 |
| Fax |
|
| Email |
akhilpatil3713@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR AKHIL RAMESH PATIL |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SMBT Institute of Medical sciences and Research centre, Dhamangaon, Nashik |
| Address |
Department of Medicine,
SMBT IMS RC. Nandi hills.
Dhamangaon. Tal. Igatpuri. Nashik
Nashik
MAHARASHTRA
422403
India |
| Phone |
9921030140 |
| Fax |
|
| Email |
akhilpatil3713@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural Research Fund , SMBT Institute of Medical sciences and Research centre, Dhamangaon, Tal. Igatpuri, Dist. Nashik |
|
|
Primary Sponsor
|
| Name |
SMBT IMS RC, Research Fund |
| Address |
SMBT IMS RC,
Dhamangaon, Nashik. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Akhil Patil |
SMBT IMS RC, DHAMANGAON |
Medicine OPD No. 10, Department of Medicine,SMBT IMS RC, Dhamangaon, Nandi hills, Tal. Igatpuri, Nashik, 422403
Nashik
MAHARASHTRA |
9921030140
akhilpatil3713@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC OF SMBT IMS & RC DHAMANGAON, GHOTI |
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 |
| Comparator Agent |
Conventional multi-meals a day pattern |
This arm subjects will follow Conventional multiple meals a day pattern for the duration of the study. |
| Intervention |
Modification of frequency of meals to only two meals per day |
Subjects in this arm will be asked to take only 2 meals 8-10 hours apart in a day for the study duration. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Recently detected Type 2 Diabetic patients willing to adopt change to two-meal and currently doing/willing to do mandatory exercise and without Nephropathy,cardiac involvement or neuropathy,not on insulin, HbA1c < 10gm%, yet to be started or on 2 or less anti-diabetic molecules. |
|
| ExclusionCriteria |
| Details |
Patients with Nephropathy,cardiac involvement or neuropathy
Patients on insulin therapy,
HbA1c > 10gm%,
Patients on more than 2 anti-diabetic molecules. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in HbA1c |
1. At enrolment
2. At 60 days
3. At 120 days
4. AT 180 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in anti-diabetic medications |
1. At enrolment
2. At 60 days
3. At 120 days
4. AT 180 days |
| Change in BMI and Waist circumference |
1. At enrolment
2. At 60 days
3. At 120 days
4. AT 180 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
05/04/2023 |
| 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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Type 2 Diabetes is the rapidly growing non communicable disease in India, with preponement of age of commencement and early organ damage. The world needs ways to prevent Type 2 Diabetes epidemic and rollback of the disease. However, the rising prevalence of Type 2 Diabetes is evidence that both lifestyle and clinical management are facing challenges. Conventional management of T2DM banks on small frequent meals, moderate exercise, and anti-diabetic medication (ADM). Many patients are now following a 2-meal a day frequency and moderate exercise (2OMEX) lifestyle with medication adjustments due to a popular campaign in Maharashtra, with a reported decline in HbA1c and even remission of Type 2 Diabetes. The recommendations strongly suggest that newly diagnosed diabetic subjects should receive a fair trial with lifestyle modification before initiating oral hypoglycaemic medication. Currently, various lifestyle modifications are popular including vegan diets, small diets for calorie restriction, intermittent fasting, and all with moderate daily/ weekly /5 days workouts. The present study aims to test this hypothesis of Type 2 Diabetes control and remission in 2OMEX and conventional management arm, the main difference being frequency of meals (2 meals only or more than 2 meals as daily routine), while moderate exercise of 45 minutes (4.5 km walk) being common to both arms. We want to do this as an open label randomized clinical study, in a tertiary institute setting, OPD subjects detected recently with uncomplicated T2D with HbA1c between 7-10 gm% and on, none or two or less oral anti-diabetic medication molecules. |