| CTRI Number |
CTRI/2025/09/094325 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
06/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Behavioral |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Vitamin D Supplements And Strength Exercises To Improve Muscle Health And Blood Sugar In People With Type 2 Diabetes |
|
Scientific Title of Study
|
Effects Of Combined Vitamin D Supplementation And Resistance Training
On Sarcopenia And Glycemic Control in Type 2 Diabetes Mellitus:
An Open-label 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 |
J Edward Arulswamy |
| Designation |
Post Graduate Student |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Department of Physiology,
SRM Medical College Hospital and Research Centre,
Kattankulathur, Chennai 603203,
Tamil Nadu, India.
Chennai
TAMIL NADU
603203
India |
| Phone |
9354251869 |
| Fax |
|
| Email |
edwardarulswamy17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Prabhavathi MD |
| Designation |
Professor |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Professor, Department of Physiology,
SRM Medical College Hospital and Research Centre,
Kattankulathur, Chennai 603203,
Tamil Nadu, India.
Chennai
TAMIL NADU
603203
India |
| Phone |
9600096800 |
| Fax |
|
| Email |
prabhavk@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Prabhavathi MD |
| Designation |
Professor |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Professor, Department of Physiology,
SRM Medical College Hospital and Research Centre,
Kattankulathur, Chennai 603203,
Tamil Nadu, India.
Chennai
TAMIL NADU
603203
India |
| Phone |
9600096800 |
| Fax |
|
| Email |
prabhavk@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| Chancellor Research Fellowship, SRM Medical College Hospital and Research Centre |
|
|
Primary Sponsor
|
| Name |
J. Edward Arulswamy |
| Address |
Department of Physiology,
SRM Medical College Hospital and Research Centre,
Kattankulathur, Chennai 603203,
Tamil Nadu, India. |
| Type of Sponsor |
Other [Self] |
|
|
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 J Edward Arulswamy |
SRM Medical College Hospital and Research Centre |
General Medicine OPD 4, Diabetic Clinic, Room Number B G 04,
Chennai
TAMIL NADU |
9354251869
edwardarulswamy17@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| SRM INSTITUTIONAL ETHICS COMMITTEE BMHR |
Approved |
| SRM INSTITUTIONAL ETHICS COMMITTEE BMHR |
Approved |
| SRM INSTITUTIONAL ETHICS COMMITTEE BMHR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M625||Muscle wasting and atrophy, not elsewhere classified, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Resistance Training |
Supervised bodyweight based resistance training program, three sessions per week for twelve weeks with progressive training intensity. |
| Comparator Agent |
Standard Care |
Routine diabetes management without Vitamin D3 supplementation or structured resistance training. |
| Intervention |
Vitamin D3 supplementation |
Oral cholecalciferol (Vitamin D3), 2000 IU daily for 12 weeks. |
| Intervention |
Vitamin D3 supplementation + Resistance Training |
Oral Cholecalciferol 2000 IU daily plus supervised bodyweight based resistance training program, three sessions per week for twelve weeks with progressive training intensity. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants must meet all of the following:
1. Diagnosis of Type Two Diabetes Mellitus (T2DM): HbA1c greater than or equal to six point five percent (IDF 2025).
2. Sarcopenia, defined by Asian Working Group for Sarcopenia (AWGS) 2019 criteria:
a. Low skeletal muscle mass (SMI less than seven point zero kilogram per meter square in men, less than five point seven kilogram per meter square in women).
b. And low muscle strength (handgrip less than twenty eight kilogram in men, less than eighteen kilogram in women).
c. Or low physical performance (gait speed less than zero point eight meter per second or chair stand greater than twelve seconds).
3. Age range: Forty to sixty years (targeting peak sarcopenia progression in T2DM).
4. Ambulatory status: Ability to perform functional tests and exercise interventions.
5. Women aged forty to sixty years with Type Two Diabetes Mellitus who are premenopausal, perimenopausal, or postmenopausal will be included, as estrogen decline during menopausal transition contributes to impaired muscle protein synthesis and mitochondrial dysfunction, increasing the risk and severity of sarcopenia in this population.
|
|
| ExclusionCriteria |
| Details |
Participants will be excluded for any of the following:
1. Diabetes subtype: Type One Diabetes Mellitus or secondary diabetes.
2. Renal impairment: Chronic kidney disease with estimated glomerular filtration rate less than thirty milliliter per minute per one point seven three meter square.
3.Comorbidities: Active malignancy, recent fractures within six months, or hospitalization within three months.
4.Pharmacological confounders:
a. Current vitamin D supplementation greater than one thousand International Units per day prior to study entry.
b. Use of anabolic steroids.
c. Use of statins.
5.Other exclusions:
a. Pregnancy or lactation.
b. Cognitive impairment or inability to provide informed consent.
c. Contraindications to exercise such as cardiovascular or musculoskeletal conditions.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in skeletal muscle index from baseline to 12 weeks across four groups, with the combined intervention expected to show the greatest improvement.
2. Change in handgrip strength from baseline to 12 weeks across four groups, with the combined intervention expected to show the greatest improvement.
3. Change in physical performance (gait speed and chair stand test) from baseline to 12 weeks across four groups, with the combined intervention expected to show the greatest improvement. |
Baseline and twelve weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in Hemoglobin A1c from baseline to twelve weeks among the four groups, with the combined intervention group expected to show greater reduction compared to the Vitamin D only group, the Resistance Training only group & the Control group.
2. Change in insulin resistance from baseline to twelve weeks assessed by Homeostatic Model Assessment for Insulin Resistance among the four groups, with the combined intervention group expected to show greater improvement compared to the Vitamin D only group, the Resistance Training only group & the Control group.
3. Correlation between serum Vitamin D levels & sarcopenia outcomes (skeletal muscle index, handgrip strength, physical performance) & glycemic outcomes (Hemoglobin A1c, insulin resistance) across all four groups.
|
Baseline & twelve weeks |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 4 |
|
Date of First Enrollment (India)
|
07/10/2025 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Diabetes mellitus is a major public health challenge, with India contributing significantly to the global burden. Type Two Diabetes Mellitus is the most common form, linked to insulin resistance, aging, and obesity, and is often complicated by sarcopenia. Sarcopenia is characterized by a decline in skeletal muscle mass, strength, and physical performance, and is more prevalent in people with diabetes.
Vitamin D plays a key role in muscle health, and deficiency is associated with a higher risk of sarcopenia. Supplementation with Vitamin D at safe daily doses can improve muscle metabolism. Resistance training is an established strategy for improving muscle strength, functional capacity, and glycemic control.
While the benefits of Vitamin D supplementation and resistance training are individually supported, their combined effect in people with Type Two Diabetes Mellitus and sarcopenia is not well studied. This randomized controlled trial will evaluate whether daily oral Vitamin D supplementation with 2000 IU and thrice-weekly supervised resistance training for twelve weeks can improve skeletal muscle mass, strength, physical performance, and glycemic control compared to either intervention alone or control. The study aims to provide evidence for a feasible and affordable strategy to address sarcopenia in individuals with diabetes. |