Ignite Creation Date:
2024-10-25 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06519942
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-04-10
Brief Title:
Muscle and Bone in Patients with Diabetes Mellitus and Neuropathy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Muscle and Bone in Patients with Diabetes Mellitus and Neuropathy
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SVT-DNP
Brief Summary:
The goal of this observational study is to evaluate muscle fiber type composition in people with type 2 diabetes mellitus T2DM with a common complication of T2DM diabetic peripheral neuropathy DNP specifically diabetic sensorimotor polyneuropathy Researchers will also look into factors related to DNP inflammation the use of energy in the cell nerve function and the tiny blood vessels in the muscle
The main question it aims to answer is Are there differences in muscle fiber type composition between persons with T2DM with and without DNP in comparison to sex and age-matched healthy peers
Participants will partake in the following tests
electromyoneurography EMNG evaluation of nerve function damage and repair for diagnosis of DNP or other diseases of the nerves
blood analysis researchers will measure insulin blood sugar lipid profile inflammation
muscle biopsy in the calf m gastrocnemius a doctor will take a small sample of muscle to evaluate the muscle shape and structure
mechanography patients will perform functional tests eg standing up from a chair researchers will evaluate maximal power and maximal force of the muscles by jumping tests
questionnaires on food intake physical activity smoking history alcohol use medical history
measurement of height weight and the comparison of the hip and waist circumference
peripheral Quantitative Computed Tomography pQCT scan of the calf for muscle density and bone density
electrocardiography ECG evaluation of electrical signals of the heart
Researchers will compare 1 patients with T2DM with DNP 2 patients with T2DM without DNP and 3 healthy persons to see if there are differences in muscle fiber type composition
The main question it aims to answer is Are there differences in muscle fiber type composition between persons with T2DM with and without DNP in comparison to sex and age-matched healthy peers
Participants will partake in the following tests
electromyoneurography EMNG evaluation of nerve function damage and repair for diagnosis of DNP or other diseases of the nerves
blood analysis researchers will measure insulin blood sugar lipid profile inflammation
muscle biopsy in the calf m gastrocnemius a doctor will take a small sample of muscle to evaluate the muscle shape and structure
mechanography patients will perform functional tests eg standing up from a chair researchers will evaluate maximal power and maximal force of the muscles by jumping tests
questionnaires on food intake physical activity smoking history alcohol use medical history
measurement of height weight and the comparison of the hip and waist circumference
peripheral Quantitative Computed Tomography pQCT scan of the calf for muscle density and bone density
electrocardiography ECG evaluation of electrical signals of the heart
Researchers will compare 1 patients with T2DM with DNP 2 patients with T2DM without DNP and 3 healthy persons to see if there are differences in muscle fiber type composition
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None