NCT06120569

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
11 months until next milestone

Study Start

First participant enrolled

September 18, 2024

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

13 days

First QC Date

October 19, 2023

Last Update Submit

November 4, 2023

Conditions

Diabetic Kidney Disease

Outcome Measures

Primary Outcomes (1)

  • HbA1C less than 7%

    Improve HbA1c by soleus muscle exercise

    One year

Secondary Outcomes (1)

  • ratio of albumin (mcg/L) to creatinine (mg/L)ratio

    One year

Study Arms (2)

Soleus muscle exercise in diabetes

EXPERIMENTAL

Soleus muscle decrease blood glucose

Device: Soleus ms exercise

Decrease glucose level by soleus exercise

EXPERIMENTAL

Soleus ms exercise in decrease blood glucose

Device: Soleus ms exercise

Interventions

Soleus ms exerciseDEVICE

Soleus muscle exercise before and after eating by half an hour

Decrease glucose level by soleus exerciseSoleus muscle exercise in diabetes

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Samir Kamal, Ass prof

    Superviosor

    STUDY DIRECTOR

Central Study Contacts

Nora Kamal, Resident

CONTACT

01002380242norahussein097@gmail.com

Ashraf El - Shazly, Prof

CONTACT

01062879221Ashrafshazly58@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Internal medicine doctor

Study Record Dates

First Submitted

October 19, 2023

First Posted

November 7, 2023

Study Start

September 18, 2024

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

November 7, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share