CTRI Number |
CTRI/2019/12/022425 [Registered on: 18/12/2019] Trial Registered Prospectively |
Last Modified On: |
17/12/2019 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Other (Specify) [Nutritional] |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Glycemic control with Low Glycemic Index preparations of Kerala cuisine in subjects with Type 2 Diabetes. |
Scientific Title of Study
|
Glycemic control with Low Glycemic Index preparations of Kerala cuisine in subjects with Type 2 Diabetes. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Nivedita Pavithran |
Designation |
Chief Dietitian |
Affiliation |
Amrita Institute of Medical Sciences and Research Centre |
Address |
AIMS-PONEKKARA.P.O AIMS-PONEKKARA.P.O Ernakulam KERALA 682041 India |
Phone |
7034028176 |
Fax |
|
Email |
brinivedita@aims.amrita.edu |
|
Details of Contact Person Scientific Query
|
Name |
Dr Harish Kumar |
Designation |
Professor and HOD |
Affiliation |
Amrita Institute of Medical Sciences and Research Centre |
Address |
AIMS-Ponekkara.P.O, Kochi-682041, Kerala, India
Ernakulam KERALA 682041 India |
Phone |
9895545190 |
Fax |
|
Email |
harishkumar@aims.amrita.edu |
|
Details of Contact Person Public Query
|
Name |
Dr Harish Kumar |
Designation |
Professor and HOD |
Affiliation |
Amrita Institute of Medical Sciences and Research Centre |
Address |
AIMS-Ponekkara.P.O, Kochi-682041, Kerala, India
Kozhikode KERALA 682041 India |
Phone |
9895545190 |
Fax |
|
Email |
harishkumar@aims.amrita.edu |
|
Source of Monetary or Material Support
|
Amrita Institute of Medical Sciences and Research Centre |
|
Primary Sponsor
|
Name |
Amrita Institute of Medical Sciences and Research Centre |
Address |
AIMS-Ponekkara.P.O, Kochi, Kerala-682041, India |
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 |
Nivedita Pavithran |
Amrita Institute of Medical Sciences and Research Centre |
AIMS-Ponekkara P.O Ernakulam KERALA |
7034028176
brinivedita@aims.amrita.edu |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee |
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 glycemic index group |
This group will include foods of Kerala cuisine which is low in glycemic index in all three meals. They will be followed up telephonically on a weekly basis and glycemic variables, cardiometabolic variables and DXA scan will be repeated after 6 months |
Comparator Agent |
Regular diet group |
This group will continue consuming their regular dietary habits which does not include foods of low glycemic index.They will be followed up telephonically on a weekly basis and glycemic variables, cardiometabolic variables and DXA scan will be repeated after 6 months |
|
Inclusion Criteria
|
Age From |
35.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
HbA1c 7-10%.
Stable on medications (OHA and insulin) for 3 months.
Duration of diabetes for atleast 1 year. |
|
ExclusionCriteria |
Details |
Pregnant women.
Gastrointestinal complications.
With metal implants. |
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
Method of Concealment
|
Alternation |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Improvement in HbA1c |
6 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
Reduction in truncal fat mass and increase in lean body mass.
Reduction cardiometabolic variables. |
6 months |
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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)
|
24/12/2019 |
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="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
None |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
The burden of Diabetes is on the rise across the globe and the rising prevalence of type 2 diabetes, particularly in developing countries appears to be mainly related to the increasing number of overweight and obese individuals all over the world. In Asians the prevalence of diabetes at any body mass index (BMI), waist circumference and waist–to–hip ratio (WHR) is higher compared to the western population.Central (truncal) obesity has been found to associate more strongly with insulin resistance and with diabetes than generalized obesity. Diabetes and obesity have emerged as a major public health problem and are increasing in rural and urban regions of India particularly Kerala. The prevalence of obesity among people with diabetes in South Kerala is 66%. Recently, the consumption of low GI ingredients of Kerala cuisine such as red rice and whole grains are being replaced with white rice and commercially available wheat flour. The effect on the consumption of locally available low glycemic index cereals of Kerala cusine on glycemic control and body composition using DXA has not been examined previously. Several studies have used dual energy X-ray absorptiometry (DXA) to study fatness and fat distribution in persons with type 2 diabetes mellitus (T2DM) compared with healthy controls, but none have reported the changes in body composition with LGI recipes of Kerala cuisine. Therefore, the purpose of this study was to investigate the effect of a 24-week intervention with low GI diet of Kerala cuisine on body composition, particularly truncal fat using DXA in people with type 2 diabetes mellitus. We hypothesized that an intervention of low GI diet using locally available ingredients of Kerala cuisine in South Indians would significantly decrease the fat mass especially truncal fat mass values and would bring about improvements in glycemic control and cardiometabolic variables . |