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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 .

 
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