| CTRI Number |
CTRI/2022/04/042186 [Registered on: 26/04/2022] Trial Registered Prospectively |
| Last Modified On: |
19/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Diet and exercise in diabetes patients with Sarcopenia |
|
Scientific Title of Study
|
Randomized controlled trial to compare the effect of dietary intervention and resistance exercises on changes in skeletal muscle strength, mass and function in Type 2 Diabetes patients with Dynapenia and Sarcopenia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Naval Kishore Vikram |
| Designation |
Professor, Department of Medicine |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Room No 8, SRB Lab, 3rd Floor, Teaching Block
New Delhi
DELHI
110029
India |
| Phone |
01126593678 |
| Fax |
|
| Email |
navalvikram@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naval Kishore Vikram |
| Designation |
Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Room no 8, SRB Lab, 3rd Floor, teaching block
New Delhi
DELHI
110029
India |
| Phone |
01126593678 |
| Fax |
|
| Email |
navalvikram@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naval Kishore Vikram |
| Designation |
Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Room no 8, SRB Lab, 3rd Floor, teaching block
New Delhi
DELHI
110029
India |
| Phone |
01126593678 |
| Fax |
|
| Email |
navalvikram@gmail.com |
|
|
Source of Monetary or Material Support
|
| INDIAN COUNCIL OF MEDICAL RESEARCH |
|
|
Primary Sponsor
|
| Name |
INDIAN COUNCIL OF MEDICAL RESEARCH |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar, New Delhi - 110029, India |
| Type of Sponsor |
Other [GOVERNMENT OF INDIA] |
|
|
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 Naval Kishore Vikram |
All India Institute of Medical Sciences, New Delhi |
Room no 8, SRB Lab, 3rd Floor, teaching block
New Delhi
DELHI |
01126593678
navalvikram@gmail.com |
|
|
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: E116||Type 2 diabetes mellitus with other specified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DIETARY MODIFICATION AND MODERATE INTENSITY PHYSICAL ACTIVITY |
Dietary intervention: Approximately, 25 kcals/kg ideal body weight/day will be given to the subjects. In the dietary intervention, concentration of protein in diet will be increased up to 20% of total energy intake an increase from 12-15% standard recommendation. Food rich in Hydroxy Methyl Butyrate (HMB), Leucine (Leu), Glutamine (Gln) and Arginine (Arg) will be increased in protein sources. India Food composition table, 2017 will be used to determine these amino acid rich sources. About 55-60 % of energy from carbohydrates will be recommendation with major complex carbohydrates. Fat proportion will be 20-25 % of total energy intake for people with diabetes.
Standard physical activity: A total of about 60 minutes of daily physical activity will be advised. It will include 30 minutes of aerobic activity (brisk walking/cycling/treadmill walking with moderate intensity), 15 minutes of work-related activity and 15 minutes of muscle strengthening exercises (sit-ups/push-ups and isometric strengthening of all major muscle groups). It will be advised to perform these exercises daily or at least five days in a week with a gradual progression in repetitions and intensity as tolerated by the patient. |
| Intervention |
DIETARY MODIFICATION AND RESISTANCE EXERCISE |
Dietary intervention: Approximately, 25 kcals/kg ideal body weight/day will be given to the subjects. In the dietary intervention, concentration of protein in diet will be increased up to 20% of total energy intake an increase from 12-15% standard recommendation. Food rich in Hydroxy Methyl Butyrate (HMB), Leucine (Leu), Glutamine (Gln) and Arginine (Arg) will be increased in protein sources. India Food composition table, 2017 will be used to determine these amino acid rich sources. About 55-60 % of energy from carbohydrates will be recommendation with major complex carbohydrates. Fat proportion will be 20-25 % of total energy intake for people with diabetes.
Structured resistance exercise: Initially all the exercises will be demonstrated by a trained physiotherapist. Therabands of different elastic strength (4 varieties) will be used and will be provided to all patients. In beginning a RET (resistance exercise therapy) program is to perform a ‘total body’ exercise routine whereby all of the major muscle groups i.e. chest, back, arms, shoulders, upper legs (quadriceps, hamstrings, and gluteal muscles), and lower legs (calves) are exercised at each exercise session of up to 60 minutes of 10 repetitions in each set and maximum of 3 such sets as tolerated by the patients with gradual progression in supervision of a physiotherapist in initial one week and home- based subsequently with the ‘total body’ routine being performed 3 times per week upto entire follow up.
|
| Comparator Agent |
RESISTANCE EXERCISE AND STANDARD DIET |
Structured resistance exercise: Initially all the exercises will be demonstrated by a trained physiotherapist. Therabands of different elastic strength (4 varieties) will be used and will be provided to all patients. In beginning a RET (resistance exercise therapy) program is to perform a ‘total body’ exercise routine whereby all of the major muscle groups i.e. chest, back, arms, shoulders, upper legs (quadriceps, hamstrings, and gluteal muscles), and lower legs (calves) are exercised at each exercise session of up to 60 minutes of 10 repetitions in each set and maximum of 3 such sets as tolerated by the patients with gradual progression in supervision of a physiotherapist in initial one week and home- based subsequently with the ‘total body’ routine being performed 3 times per week upto entire follow up.
Standard Diet: Approximately, 25 kcals/kg ideal body weight/day will be given to the subjects. About 55-60 % of energy from carbohydrates will be recommendation with major complex carbohydrates. Proteins provide will be 12-15 % of the total energy intake. Fat proportion will be 20-30 % of total energy intake for people with diabetes.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ï‚¢ Patients age between 18-60yrs.
ï‚¢ Patients diagnosed with Type -2 DM. Along with Sarcopenic
ï‚¢ Hand grip strength Men <28 kg, Women <18 kg
ï‚¢ Appendicular skeletal muscle mass/height2: Men<7.0kg/m2, Women <5.4 kg/m2.
 SPPB≤8 (The maximum score on the SPPB is:12)
ï‚¢ 4-minute gait speed <0.8m/s.
|
|
| ExclusionCriteria |
| Details |
ï‚¢ Patient with concomitant severe heart, liver or renal diseases.
ï‚¢ Pregnancy and Lactation, and any physical deformity or loss of extremity.
ï‚¢ HIV, HbsAg and HCV positive patients.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| muscle strength, muscle mass and muscle function, biochemical parameters, body composition |
At baseline 6 weeks and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Anthropometric measures and Biomarkers |
Baseline and 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
02/05/2022 |
| 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)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NONE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response (Others) -
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response (Others) -
- For what types of analyses will this data be available?
Response (Others) -
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 02-05-2022 and end date provided 01-05-2027?
Response (Others) -
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
a.
Background: Sarcopenia describes
declines in muscle mass and strength and has been implicated as both a cause
and consequence of T2DM. T2DM is characterized by insulin resistance, increased
advanced glycation end products (AGEs), a proinflammatory phenotype and
oxidative stress, which can lead to micro- and macro-vascular complications which
may lead to losses in skeletal muscle mass, strength, and function, potentially
leading to the development of dynapenia and sarcopenia
b.
Novelty: this is a first intervention which includes
dietary and resistant exercise for management of dynapenia/sarcopenia in type 2
diabetes subjects on Indian population.
c. Objectives:
To
compare the effect of dietary intervention (DI) with resistance exercise (RE)
verses standard diet (SD) and standard exercise (SE) and in other arm effect of
dietary intervention (DI) with standard exercise (SE) verses standard diet (SD)
and resistance exercise (SE) on skeletal muscle mass and function and physical
performance in type 2 diabetes subjects with Dynapenia or sarcopenia. Glycemia,
lipids profile, insulin sensitivity and subclinical inflammation, adherence to
the intervention will also be compared in each group.
d.
Methods: The study is a 3-armed randomized controlled trial
where combination of dietary intervention, resistance exercise and standard
diet and standard exercise will be compared. Total 150 subjects will be
recruited with 50 subjects in each arm.
e.
Expected outcome: A
combination of dietary intervention along with resistance exercises is likely
to result in improved muscle mass and function in sarcopenic individuals. This
in turn will be helpful in improving metabolic abnormalities such as insulin
resistance, dyslipidemia and dysglycemia. |