Effect of Soleus Muscle Push Ups on Oxidative Stress and Inflammatory Markers, Soleus Endurance, and Adipocytokines Between Type 2 Diabetic, Overweight/Obese and Normal Weight Individuals.

The study aims to investigate the impact of Soleus Push Ups (SPU) on Soleus Muscle endurance, Oxidative Stress Markers, Inflammatory markers and Adipocytokines among people in the United Arab Emirates. This will be a pre-post intervention study with participants divided into three groups: Lean normal metabolic profile, metabolically healthy overweight/obese, and patients with Type 2 Diabetes Mellitus. Assessment of anthropometry and body composition, Soleus Muscle Endurance, blood tests for Inflammatory Markers, Oxidative Stress Markers, and Adipocytokines will be conducted pre and post-intervention.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity; Overweight; Diabete Type 2
• Intervention / Treatment: Other: Soleus Muscle Push Up Exercise; Other: Other Exercise

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amenah Abdelazim, BPT; Phone Number: +971554590707; Email: aabdelazim@sharjah.ac.ae
• Study Contact Backup: Name: Kalyana Reddy, PhD; Phone Number: +971503614889; Email: kreddy@sharjah.ac.ae

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Residents of UAE, both males and females
• Ages 20-50 years
• Uncomplicated Type 2 Diabetic on meds,
• Normal lean BMI
• Overweight and Obese

Exclusion Criteria:

• Recent orthopedic surgery in the LLs
• Pain in the LLs starting from Hips to Ankle.
• Presence of Varicose Veins in the LLs
• Present History of any cardiovascular condition
• Pregnant females
• Morbid Obesity
• Diabetics undergoing Insulin therapy only
• Smokers and alcohol consumption

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group	Other: Other Exercise; Participants will be asked to continue their regular lifestyle
Active Comparator: Interventional group	Other: Soleus Muscle Push Up Exercise; Members will be asked to do the SPUs for 270 minutes/day for most days of the week (minimum 5 days) for 3 months: Begin seated on a bench or chair so knees form a 90-degree angle with feet flat on the floor and toes pointed forward. Keep spine straight and shoulders back (not hunched or rounded forward).; Using a slow and controlled tempo, push toes into the floor and lift heels off the ground.; Hold for one to two seconds, pushing down on the balls of feet. Keep your thigh muscles relaxed.; Slowly lower heels and return to start. That's 1 rep. Without shoes Educational session will be given before the intervention time WhatsApp messages will be sent 1-2 times/day to remind the participants to continue doing the exercise and ascertain compliance. Also, the participants are required to daily fill logbook about the duration (in minutes) of the SPU that they did.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adipocytokine levels in the blood	Measured in μg/ml, using blood test by specialized personnel	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Soleus Muscle endurance through Heel Raise Test. • Inflammatory and Oxidative Stress markers through blood sample.	Measured as a number, in repetitions. Detailed procedure described previously.	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI	kg/m2	3 months
Anthropometric data including weight, height and fat percentage	Measured in kgs, cms and % respectively	3 months
Physical Activity and Food habits	Questionnaire (International Physical Activity Questionnaire and Food Frequency Questionnaire)	3 months
Venous blood specimens	Measured in mL, using blood test by specialized personnel	3 months

Collaborators and Investigators

• Sponsor: University of Sharjah

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: May 22, 2024
• First Submitted That Met QC Criteria: June 4, 2024
• First Posted (Actual): June 10, 2024

Study Record Updates

• Last Update Posted (Actual): June 10, 2024
• Last Update Submitted That Met QC Criteria: June 4, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Overnutrition; Nutrition Disorders; Body Weight; Diabetes Mellitus, Type 2; Overweight
• Other Study ID Numbers: USharjah1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In case of the need for further expansion of the research, the information might be shared with other researchers in the university without exposure of any personal information or names of participants.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No