| CTRI Number |
CTRI/2025/08/092869 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
11/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Effect of Low Carbohydarte diet education in managing and reversing the Diabetes Mellitus aged 30-50 years |
|
Scientific Title of Study
|
A Randomised control trial to assess the feasibility, acceptability and effect of low carbohydrate dietary education in glycaemic control and diabetic remission among type II Diabetes mellitus patients aged 30-50 years- Mixed method study. |
| 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 Buvana Loshana K |
| Designation |
Post graduate |
| Affiliation |
Indira Gandhi Medical College and Research Institute |
| Address |
Indira Gandhi Medical College and Research Institute,Department of Community Medicine, Vazhudavour road,Kadhirkamam, puducherry
Pondicherry
PONDICHERRY
605009
India |
| Phone |
7708033681 |
| Fax |
|
| Email |
loshana.r.k@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prakash M |
| Designation |
Associate Professor |
| Affiliation |
Indira Gandhi Medical College and Research Institute |
| Address |
Indira Gandhi Medical College and Research Institute,Department of Community Medicine, Vazhudavour road,Kadhirkamam, puducherry.
Pondicherry
PONDICHERRY
605009
India |
| Phone |
8903586064 |
| Fax |
|
| Email |
drmanivelprakash@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Buvana Loshana K |
| Designation |
Post graduate |
| Affiliation |
Indira Gandhi Medical College and Research Institute |
| Address |
Indira Gandhi Medical College and Research Institute,Department of Community Medicine, Vazhudavour road,Kadhirkamam, puducherry
Pondicherry
PONDICHERRY
605009
India |
| Phone |
7708033681 |
| Fax |
|
| Email |
loshana.r.k@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Medical College and Research Institute |
| Address |
Indira Gandhi Medical College and Research Institute, Vazhudavour Road, Kadhirkamam, Puducherry 605009 |
| 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 Buvana Loshana K |
Field Practice Areas of Indira Gandhi Medical college and Research institute |
Indira Gandhi Medical college and Research institute, Room No 5, Department of Community Medicine, Vazhudavour Road, Kadhirkamam, Pondicherry
Pondicherry
PONDICHERRY |
7708033681
loshana.r.k@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee (Human Studies) Indira Gandhi Medical College and Research Institute |
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 |
Low Carbohydrate dietary Education |
less than 130g/day of carbohydrate foods education are recommended per day for a average 2000kcal energy required. 12 months of intervention |
| Comparator Agent |
Standard Programmatic diet plan |
50-60% of total calories from carbohydrates, preferably from
complex carbohydrates, about 10-15% from proteins and 20-30% from both visible
and invisible fat.
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Type II – Diabetes mellitus patients aged between 30 and 50 years and registered at the Health & wellness centres.
2.Duration of diabetes less than 2 years
|
|
| ExclusionCriteria |
| Details |
1.Patient with known complications of Diabetes mellitus such as foot ulcer, retinopathy, nephropathy, CAD, CVA.
2.Currently on insulin therapy
3.Intensive pharmacological treatment of more than 2 antidiabetic drugs.
4.Pregnant or lactating women
5.Individuals with significant psychiatric illness or cognitive impairment affecting participation.
6.Participants currently following any structured dietary intervention or enrolled in another clinical trial.
7.Migrants or individuals unlikely to complete follow-up due to relocation.
8.Patient following other alternative forms of medicine.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Glycaemic control |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Diabetic remission
2.effect of diet in Diabetic complications in Neuropathy, Microalbuminuria and dyslipidaemia
|
2 years |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
27/08/2025 |
| 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 Applicable |
| 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
|
This is a Randomised control interventional study involving two clusters from Karikalampakkam and Lawspet subcentres, randomized into study and control groups.
-
Baseline Data Collection: Informed consent will be obtained. Sociodemographic details, clinical examinations, and investigations including FBS, HbA1c, and lipid profile will be recorded.
-
Glycemic Monitoring: GMR (Glucose Monitoring Record) will be assessed monthly via Health and Wellness Centres (HWC) by the investigator. This data will guide anti-diabetic drug titration (intensification or de-intensification) alongside HbA1c test willl be done on 3.6.and 12 month and symptoms of hypoglycemia or hyperglycaemia are assesed.
-
Intervention (Study Group): Participants will receive dietary education on Low carbohydrate diet weekly for the first month, with BP and glucose checks. Biweekly phone/WhatsApp follow-ups at Weeks 6, 8, and 10 will monitor diet adherence. In-person follow-ups are scheduled at Month 3 and Month 6 .
-
Control Group: Will receive standard ICMR guidelines dietary education with monthly follow-ups for 3,6 months.
-
Final Follow-up: Both groups will be assessed at 12 months for outcome evaluation.
-
Qualitative Component: Focused Group Discussions (FGDs) will be conducted with selected individuals to assess the feasibility, acceptability, challenges, and perceived benefits of dietary interventional education. |