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

Sponsor

Nora Hussein Kamal (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06120569

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Days)

Study Details

Study Description

Brief Summary

Evaluate the role of Soleus muscle exercise in management diabetic kidney disease

Condition or Disease	Intervention/Treatment	Phase
Diabetic Kidney Disease	Device: Soleus ms exercise	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 18, 2024

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

HbA1C less than 7% [One year]
Improve HbA1c by soleus muscle exercise

Secondary Outcome Measures

ratio of albumin (mcg/L) to creatinine (mg/L)ratio [One year]
Improve alb /creatinine ratio

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Nora Hussein Kamal

Investigators

Study Director: Samir Kamal, Ass prof, Superviosor

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Pudmed

Publications

None provided.

Responsible Party:

Nora Hussein Kamal, Internal medicine doctor, Assiut University

ClinicalTrials.gov Identifier:

NCT06120569

Other Study ID Numbers:

Soleus ms exercise in diabetis

First Posted:

Nov 7, 2023

Last Update Posted:

Nov 7, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Kidney Diseases

Diabetic Nephropathies

Study Results

No Results Posted as of Nov 7, 2023