| CTRI Number |
CTRI/2024/05/067382 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
14/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Nutritional] |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Utility of low glycaemic index of rice in the management of type 2 diabetes |
|
Scientific Title of Study
|
Utility of low glycaemic index of rice in the management of type 2 diabetes: randomized cross-over trial on glycemic control, related parameters and quality of life |
| Trial Acronym |
RICE TRIAL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ravinder Goswami |
| Designation |
Professor |
| Affiliation |
All India Institute of Sciences |
| Address |
Department of Endocrinology and Metabolism, All India Institute of Medical Sciences, Ansari Nagar, New Delhi
New Delhi DELHI 110029 India |
| Phone |
09818130879 |
| Fax |
|
| Email |
gosravinder@hotmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Ravinder Goswami |
| Designation |
Professor |
| Affiliation |
All India Institute of Sciences |
| Address |
Department of Endocrinology and Metabolism, All India Institute of Medical Sciences, Ansari Nagar, New Delhi
New Delhi DELHI 110029 India |
| Phone |
09818130879 |
| Fax |
|
| Email |
gosravinder@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Ravinder Goswami |
| Designation |
Professor |
| Affiliation |
All India Institute of Sciences |
| Address |
Department of Endocrinology and Metabolism, All India Institute of Medical Sciences, Ansari Nagar, New Delhi
New Delhi DELHI 110029 India |
| Phone |
09818130879 |
| Fax |
|
| Email |
gosravinder@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Biotechnology.Ministry of Science and Technology, Government of India, CGO complex, Lodhi Road, New Delhi-110003, India |
|
|
Primary Sponsor
|
| Name |
Department of Biotechnology Ministry of Science and Technology Government of India |
| Address |
Department of Biotechnology, 7th floor, Block-2, CGO complex, Lodhi Road, New Delhi- 110003, India |
| Type of Sponsor |
Government funding agency |
|
|
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 Ravinder Goswami |
All India Institute of Medical Sciences, New Delhi |
Department of Endocrinology and Metabolism, AIIMS, Ansari Nagar South DELHI |
09818130879
gosravinder@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E08-E13||Diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Continue with standard diet pattern without rice |
Patints will be randomised in two groups. THese two groups will be cross over for intrevention and comparator purpose. In the first three months, group 2 subjects will be instructed to continue their regular dietary pattern without rice and they will be assessed for their glycaemic status.
Group 1 subjects, after first three months of intervention with low glycaemic index rice, would be advised to continue their regular diet without including rice in the diet for next three months of intervention and assessed for their glycaemic status. |
| Intervention |
Intervention with daily intake of fixed amount of rice with low glycemic index during lunch |
Group 1 would be advised to take cooked rice with best low Glycaemic index as the essential meal in the lunch (covering 200 calories) for first three months of the study period. Each subject in group 1 will be given 5 kg rice/every month for 3 months. To achieve total compliance the entire family supply of rice will be given. After cross-over, Group 2 would be advised to take low glycaemic index rice for next three months as described for group 1. All the study participants will be assessed for their glycaemic status during intervention period. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
62 patients with type 2 diabetes mellitus of at least one year duration (male and female), of 30-60 years, with no chronic gastrointestinal, thyroid disorder, food allergies, with HbA1c less than 8.0 % without any chronic micro or macrovascular complications (based on serum creatinine and urinary albumin excretion and fundus examination) would be included. Additional criteria would be willing ness to include rice during lunch every day for three months. |
|
| ExclusionCriteria |
| Details |
Patients with type 2 diabetes mellitus with any chronic micro or macrovascular complications (based on serum creatinine and urinary albumin excretion and fundus examination), on insulin therapy, with active infection, with HbA1c 8.0 % or above will be excluded. Those with resident outside Delhi and NCR would be excluded. Besides, patients with BMI above 35 kg/m2 would also be excluded. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome would be from the results of use of low glycemic food from patients with T2D. There is possibility that three months of use of low glycaemic index rice would lead to improved compliance with diet, glycemic control as revealed by continuous glucose monitoring and metabolic parameters i.e., glycated hemoglobin. |
After 7 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in the other metabolic parameter i.e, lipid profile and also improvement in the quality of life in type 2 diabetes mellitus patients |
After 7 months |
|
|
Target Sample Size
|
Total Sample Size="62" Sample Size from India="62"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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="3" 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
|
India has high burden of type 2 diabetes mellitus (T2D). Glycemic control is important to reduce chronic micro vascular complications. Though lifestyle intervention, dietary changes, and drug therapy are important, quality of life should be maintained by not restriction their long held dietary practices. In practice, patients often request rice for at least once a day in meals to maintain pleasure of eating. However, rice is considered carbohydrate rich worsening glycemic control. We would assess the effect of rice with low glycemic index (GI) on glycemic control, related parameters i.e., insulin, lipids and quality of life in T2D. The study will be carried out in a step wise manner. In stage 1 we would assess GI of 5 rice varieties (four with low and one with high GI) in healthy controls. Stage 2 would assess similar GI in T2D with HbA1c < 8.0%. Stage 3 would be a randomized crossover trial in T2D with intervention of regular intake of low GI rice in meal once per day for 3 months. An open labelled randomized cross-over trial would be carried out in type 2 diabetics with intervention of daily intake of fixed amount of rice with low glycemic index during lunch. After inclusion and exclusion criteria, 62 patients with T2D will be included. At enrolment a detailed history, physical examination including anthropometry, questionnaire on quality of life (SF36), days with dietary compliance in a month as per a visual analogue scale would be recorded. Blood glucose, Lipid profile, HbA1c, other standard investigation including complete blood count, liver and kidney function test would be done. Patients will be block randomized into Group 1 and 2. For first 3 months, group 1 would be advised cooked rice with best low GI as the essential meal in the lunch (covering 200 calories). Each subject in group 1 will be given 5 kg rice/every month for 3 months. To achieve total compliance the entire family supply of rice will be given. Group 2 will be instructed to continue with their regular diet pattern without rice for three months. After one month of wash over period, groups will be crossed with regard to intervention advise i.e, group 1 will continue standard diet without rice and group 2 will be advised to take low GI rice during lunch for next three months. All subjects will be assessed for glycaemic status including glycated hemoglobin (HbA1c) and glucose moniting by free style Libre during the study period. Final assessment would be carried out at the end of seven months. All investigations which carried out at baseline will be repeated at their last follow-up visit. |