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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06120569
Other study ID # Soleus ms exercise in diabetis
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 18, 2024
Est. completion date October 2024

Study information

Verified date November 2023
Source Assiut University
Contact Nora Kamal, Resident
Phone 01002380242
Email norahussein097@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 45
Est. completion date October 2024
Est. primary completion date October 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Intervention

Device:
Soleus ms exercise
Soleus muscle exercise before and after eating by half an hour

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Nora Hussein Kamal

Outcome

Type Measure Description Time frame Safety issue
Primary HbA1C less than 7% Improve HbA1c by soleus muscle exercise One year
Secondary ratio of albumin (mcg/L) to creatinine (mg/L)ratio Improve alb /creatinine ratio One year
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