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CTRI Number  CTRI/2025/02/080070 [Registered on: 07/02/2025] Trial Registered Prospectively
Last Modified On: 24/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Low Carbohydrate Diet and Physical Activity on HbA1c outcomes among Diabetic and Prediabetic teaching professionals - A Randomised Controlled Trial  
Scientific Title of Study   Effect of Low Carbohydrate Diet and Physical Activity on HbA1c outcomes Among Diabetic and Prediabetic teaching professionals- A Randomized controlled trial 
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. Abhirami MV 
Designation  Post graduate 
Affiliation  Sri Lakshmi Narayana institute of Medical Sciences 
Address  Department of Community Medicine Sri Lakshmi Narayana Institute of Medical Sciences, Ossudu, Agaram village, Villianur commune, Koodapakkam post

Pondicherry
PONDICHERRY
605502
India 
Phone  9344793076  
Fax    
Email  abhirami@live.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Rajini 
Designation  Professor and Head of the Department 
Affiliation  Sri Lakshmi Narayana institute of Medical Sciences 
Address  Department of Community Medicine Sri Lakshmi Narayana Institute of Medical Sciences, Ossudu, Agaram village, Villianur commune, Koodapakkam post

Pondicherry
PONDICHERRY
605502
India 
Phone  9865233325  
Fax    
Email  rajsenspm@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Abhirami MV 
Designation  Post graduate 
Affiliation  Sri Lakshmi Narayana institute of Medical Sciences 
Address  Department of Community Medicine Sri Lakshmi Narayana Institute of Medical Sciences, Ossudu, Agaram village, Villianur commune, Koodapakkam post

Pondicherry
PONDICHERRY
605502
India 
Phone  9344793076  
Fax    
Email  abhirami@live.com  
 
Source of Monetary or Material Support  
Sri Lakshmi Narayana institute of medical sciences, puducherry 
 
Primary Sponsor  
Name  Sri Lakshmi Narayana Institute of Medical Sciences 
Address  Department of Community Medicine Sri Lakshmi Narayana Institute of Medical Sciences, Ossudu, Agaram village, Villianur commune, Koodapakkam post, Pondicherry-605502 
Type of Sponsor  Private medical college 
 
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 
Dr Abhirami MV  Sri Lakshmi Narayana Institute of Medical Sciences  Department of Community Medicine, Sri Lakshmi Narayana Institute of Medical Sciences, Osudu Agaram village, Villianur commune, koodapakkam post
Pondicherry
PONDICHERRY 		 9344793076

abhirami@live.com 
 
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 Carbohydrate Diet and physical activity  Low carbohydrate diet range of my study is daily consumption of carbohydrate less than 200 g/day The physical activity of my study indicates brisk walking for 30-45 minutes/day for a period of 6 months.  
Comparator Agent  Normal routine diet and routine physical activity  no diet or physical activity for the comparator group 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Diabetics and Pre-diabetics among teaching professionals
Current diabetic status, as defined by HbA1c of diabetes ≥6.5% and HbA1C of pre-diabetes ≥5.7-6.4%.
 
 
ExclusionCriteria 
Details  Critical illness, type 1 diabetes, taking insulin, serious cardiovascular disease, renal impairment, severe food allergy or intolerance, pregnancy, lactation or planning for pregnancy during the study, alcohol dependence syndrome, hemoglobin disorders, and impending surgery.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To find out the low carbohydrate diet and physical activity will show improvement in controlling glycemia in individuals with diabetes and prediabetes and their HbA1c remission.
 		 Baseline, 3 months and 6 months
 
 
Secondary Outcome  
Outcome  TimePoints 
comparison of HbA1c outcomes between the control & intervention group after 6 months  Baseline, 3 months & 6 months 
 
Target Sample Size   Total Sample Size="168"
Sample Size from India="168" 
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 3 
Date of First Enrollment (India)   20/02/2025 
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="0"
Months="6"
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  

Topic: Effect of Low Carbohydrate Diet and Physical Activity on HbA1c outcomes Among Diabetic and Prediabetic teaching professionals- A Randomized controlled trial

Introduction:

Type 2 Diabetes mellitus is a chronic condition with a major impact on the lives and well-being of individuals, families, and communities worldwide.
The International Diabetes Federation (IDF) estimates that there are 72.9 million people with diabetes in India in 2017, which is projected to rise to 134.3 million by the year 2045.
Insulin resistance and impaired beta cell function are core defects in type 2 diabetes responsible for the pathophysiological disturbances leading to hyperglycemia, dyslipidemia and hypertension.

 

Diagnostic criteria for diabetes:

Fasting plasma glucose mg/dl 
 2-hour post 75 g glucose 200 mg/dl 
 Glycated Hemoglobin (HbA1c) %
 Random plasma glucose 200 mg/dl

Operational definition: 

Type 2 Diabetes with HbA1c level 
 Prediabetes with HbA1c level 5.7- 6.4%
Low carbohydrate diet range of my study is daily consumption of carbohydrate less than 200 g/day.
The physical activity of my study indicates brisk walking for 30-45 minutes/day for a period of 6 months.

Aim:

Effectiveness of behavioral intervention in promoting Low Carbohydrate Diet and Physical activity among diabetic and prediabetic teaching professionals.

Objective: 

 Among the diabetic and prediabetic teaching professionals in selected colleges of Puducherry
To compare the HbA1c level in both control and intervention group before and after intervention. 
To study and compare the effectiveness of low carbohydrate diet and routine physical activity among control and intervention group before and after intervention.

Methodology:

Study design: Open label Randomized Controlled Trial.
Study setting:  The study will be conducted in Engineering and Arts & Science colleges of Puducherry.
Study participants:  Teaching faculties of Engineering and Arts & Science college will be selected as per the inclusion criteria.
Sample Size Estimation:
Based on the study done by Kirsten et al, considering P1 as 53% and P2 as 32% with 95% Confidence level and 80% power we estimated the sample size to be 168 by using the formula, 
     n = (Zα/2+Zβ)2 * (p1(1-p1)+p2(1-p2)) / (p1-p2)2

Data collection:

 An announcement will be made in the colleges regarding the study. After getting the consent, all the eligible participants will be screened. 
A pretested, validated questionnaire will be used to gather information regarding the Socio Demographic characteristics of study population such as name, age, sex, occupation, place of residency, education, socio economic status, anthropometry, diabetic status, drug history, personal history and mental history.

Method of data collection:

study will be explained after which a written informed consent is taken.
Direct face to face interview conducted using structured questionnaire.
Blood investigation for HbA1c at 0 and 6 months will be done.

Expected outcome:

 This study will find out that low carbohydrate diet and physical activity will show improvement in controlling glycemia in individuals with diabetes and prediabetes and their HbA1c remission.
 Difference in HbA1c outcome between control and intervention group will be analyzed.

 

 

 
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