Evaluate the Role of Soleus Muscle Exercise in Glycaemic Control in Diabetic Kidney Disease Patients

November 4, 2023 updated by: Nora Hussein Kamal
Evaluate the role of Soleus muscle exercise in management diabetic kidney disease

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

management of diabetic kidney disease. To enhance their glycemic control, diabetic patients are advised to perform 150 minutes per week of moderate-to-vigorous aerobic activity Diabetic patients with regular physical activity have reduced daily insulin dose with more glycemic control. In addition to glycemic control, it has also been postulated that the addition of brief intervals of high intensity, sprint -type exercise to aerobic exercise can decrease the risk of late nocturnal hypoglycemic episodes Marc T. Hamilton et al., 2022, reported that the human soleus muscle could raise local oxidative metabolism to high levels for hours without fatigue, during a type of soleus-dominant activity while sitting (soleus push up exercise), even in unfit volunteers. They reported that soleus push up exercise can improve systemic VLDL-triglyceride and glucose homeostasis by a large magnitude, e.g., 52% less postprandial glucose excursion (∼50 mg/dL less between ∼1 and 2 h) with 60% less hyperinsulinemia. Muscle biopsies revealed there was minimal glycogen use. This can be explained that the soleus doesn't rely completely on intramuscular glycogen, Instead, it uses a mixture of fuels from glucose and lipoproteins.

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients age 18-60 yrs.,
  • patients with Diabetic kidney disease, not on dialysis
  • with stabilized diabetic treatment regimen for 3 months before participating in the study

Exclusion Criteria:

  • advanced osteoarthritis of lower limb joints
  • advanced poly neuropathic patients
  • CKD type V on dialysis
  • Diabetic Foot
  • hemophilia
  • bleeding tendency
  • AKI
  • other causes of chronic kidney disease
  • patients refuse to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Soleus muscle exercise in diabetes
Soleus muscle decrease blood glucose
Device: Soleus ms exercise
Soleus muscle exercise before and after eating by half an hour
Experimental: Decrease glucose level by soleus exercise
Soleus ms exercise in decrease blood glucose
Device: Soleus ms exercise
Soleus muscle exercise before and after eating by half an hour

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1C less than 7%
Time Frame: One year
Improve HbA1c by soleus muscle exercise
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ratio of albumin (mcg/L) to creatinine (mg/L)ratio
Time Frame: One year
Improve alb /creatinine ratio
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nora Hussein Kamal

Investigators

  • Study Director: Samir Kamal, Ass prof, Superviosor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 18, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

October 19, 2023

First Submitted That Met QC Criteria

November 4, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 4, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soleus ms exercise in diabetis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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