Diabetic Kidney DiseaseNCT06120569
Evaluate the Role of Soleus Muscle Exercise in Glycaemic Control in Diabetic Kidney Disease Patients
A study testing Soleus ms exercise in people with Diabetic Kidney Disease, run by Nora Hussein Kamal.
Trial summary
Evaluate the role of Soleus muscle exercise in management diabetic kidney disease Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Kidney Disease
- What is being tested?
- Soleus ms exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 18 Sep 2024to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- advanced osteoarthritis of lower limb joints
- advanced poly neuropathic patients
- CKD type V on dialysis
- Diabetic Foot
- hemophilia
- bleeding tendency
Show all 9Show fewer
- AKI
- other causes of chronic kidney disease
- patients refuse to participate in the study
Trial locations and contacts
No sites are listed yet.
About this study
Evaluate the role of Soleus muscle exercise in management diabetic kidney disease
Read the 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.
- Conditions
- Diabetic Kidney Disease
- Being tested
- Soleus ms exercise
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soleus ms exerciseDevice
Soleus muscle exercise before and after eating by half an hour
| Study group | Role | What they receive |
|---|---|---|
| Soleus muscle exercise in diabetes | Experimental | Soleus muscle decrease blood glucose Receives: Device: Soleus ms exercise |
| Decrease glucose level by soleus exercise | Experimental | Soleus ms exercise in decrease blood glucose Receives: Device: Soleus ms exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1C less than 7%
Improve HbA1c by soleus muscle exercise
Measured: One year
Secondary outcomes (1)
ratio of albumin (mcg/L) to creatinine (mg/L)ratio
Improve alb /creatinine ratio
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start18 Sep 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nora Hussein Kamal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nora Hussein Kamal, Assiut University
- Investigators
- Samir Kamal, Ass prof, Study director, Superviosor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06120569
- Sponsor's protocol ID
- Soleus ms exercise in diabetis
- Status last verified
- Nov 2023
- First submitted
- 19 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Role of Soleus Muscle Exercise in Glycaemic Control in Diabetic Kidney Disease Patients
- ClinicalTrials.gov ID
- NCT06120569
- Acronym / sponsor ID
- Soleus ms exercise in diabetis
- Conditions
- Diabetic Kidney Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Nora Hussein KamalUniversity, hospital or other
- Study start
- 18 Sep 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the role of Soleus muscle exercise in management diabetic kidney disease
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Soleus muscle exercise in diabetes | Experimental | Device: Soleus ms exerciseSoleus muscle decrease blood glucose |
| Decrease glucose level by soleus exercise | Experimental | Device: Soleus ms exerciseSoleus ms exercise in decrease blood glucose |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- advanced osteoarthritis of lower limb joints
- advanced poly neuropathic patients
- CKD type V on dialysis
- Diabetic Foot
- hemophilia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soleus ms exerciseSoleus muscle exercise before and after eating by half an hour | Device | Decrease glucose level by soleus exercise, Soleus muscle exercise in diabetes |
Primary outcome
HbA1C less than 7%
Time frame: One year
Improve HbA1c by soleus muscle exercise
1 secondary outcome
ratio of albumin (mcg/L) to creatinine (mg/L)ratio
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- PudmedLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samir Kamal, Ass prof study director
Superviosor
Questions about this trial
What is this clinical trial studying?
A study testing Soleus ms exercise in people with Diabetic Kidney Disease, run by Nora Hussein Kamal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nora Kamal, Resident (01002380242, norahussein097@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1C less than 7% (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.