| CTRI Number |
CTRI/2024/05/068182 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
21/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of sleep quality and suger control in type 2 diabetic individuals with different level of physical activity. |
|
Scientific Title of Study
|
Comparison of sleep quality and glycemic control in type 2 diabetic individuals with different level of physical activity. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Avanti potdar |
| Designation |
post graduate student |
| Affiliation |
DE societys Brijlal Jindal College of Physiotherapy, Pune |
| Address |
Department of Cardiovascular and respiratory physiotherapy, DE societys Brijlal Jindal College of Physiotherapy, Fergusson college campus, FC road, Pune
Pune
MAHARASHTRA
411004
India |
| Phone |
7249238050 |
| Fax |
|
| Email |
potdaravanti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shreya Rahul Dhake PT |
| Designation |
HOD and Asso. Professor |
| Affiliation |
DE societys Brijlal Jindal College of Physiotherapy, Pune |
| Address |
Department of Cardiovascular and respiratory physiotherapy, DE societys Brijlal Jindal College of Physiotherapy, Fergusson college campus, FC road, Pune
Pune
MAHARASHTRA
411004
India |
| Phone |
9892252731 |
| Fax |
|
| Email |
shreya.dhake@despune.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shreya Rahul Dhake PT |
| Designation |
HOD and Asso. Professor |
| Affiliation |
DE societys Brijlal Jindal College of Physiotherapy, Pune |
| Address |
Department of Cardiovascular and respiratory physiotherapy, DE societys Brijlal Jindal College of Physiotherapy, Fergusson college campus, FC road, Pune
Pune
MAHARASHTRA
411004
India |
| Phone |
9892252731 |
| Fax |
|
| Email |
shreya.dhake@despune.org |
|
|
Source of Monetary or Material Support
|
| Avanti potdar
Department of Cardiovascular and respiratory physiotherapy, DE societys Brijlal Jindal College of Physiotherapy, Fergusson college campus, FC road, Pune |
|
|
Primary Sponsor
|
| Name |
Avanti potdar |
| Address |
Department of Cardiovascular and respiratory physiotherapy, DE societys Brijlal Jindal College of Physiotherapy, Fergusson college campus, FC road, Pune |
| Type of Sponsor |
Other [] |
|
|
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 |
| Avanti Potdar |
DE societys Brijlal Jindal College of Physiotherapy |
Department of Cardiovascular and respiratory physiotherapy, DE societys Brijlal Jindal College of Physiotherapy, Fergusson college campus, FC road, Pune
Pune
MAHARASHTRA |
7249238050
potdaravanti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, DE societys Brijlal Jindal College of Physiotherapy, Pune |
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 |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 35-60 years.
2. Both males and females.
3. Duration of diabetes 1 year and more and on regular medication.
4. Who has HbA1c report for the last 3 months.
|
|
| ExclusionCriteria |
| Details |
1. Any complications related to Diabetes(like extremity amputations, peripheral neuropathy, nephropathy, cardiovascular disease, cerebrovascular disease, and retinopathy).
2. Any Musculoskeletal, Neurological, Cardiorespiratory problem like RA,
stroke, COPD, CKD, retinopathy, amputation, fractures, etc.
3. Any chronic debilitating disease causing limitation of activity.
4. Gestational diabetes
5. Inability to communicate due to physical or mental disability.
6. Patient is a known case of or diagnosed with psychiatric illness.
7.Patients taking altering medications (medications containing caffeine, cocaine, Amphetamine)
8.Patients with other serious diseases such as cancer, severe infection, severe heart, lung, or brain disease
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sleep Quality scale |
At first contact (0 -84) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Glycemic control |
At first contact (0 -16) |
| International Physical Activity Scale (IPAQ) |
At first contact |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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)
|
21/06/2024 |
| 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)
|
Not Yet Recruiting |
| 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
|
Diabetes mellitus is a chronic heterogeneous metabolic disorder may resulting in fat, protein, and carbohydrates are connected to long-term harm, dysfunction, and the emergence of macro- and microvascular problems. Diabetes management is multifaceted, involving lifestyle modifications, medication, and monitoring. Sleep deprivation increases the plasma glucose level and cause high insulin resistance, resulting in impaired glycemic control. Along with Sleep quality, physical activity is one of the factors that affect glycemic management. Exercise-induced glycemic control is mostly explained by an increase in whole-body insulin sensitivity. Understanding the changes between sleep quality and glycemic control within individuals of different level of physical activity can contribute to the development of preventive strategies. Thus, the study aims to compare provide command on sleep quality and glycemic control changes with change in physical activity in type 2 DM individuals and thus help in setting better strategies in diabetes management . Null Hypothesis(H0) :There is no difference in sleep quality and glycemic control of type 2 diabetic individuals with different levels of physical activity. Alternate Hypothesis (H1) :There is a difference in sleep quality and glycemic control of type 2 diabetic individuals with different levels of physical activity. |