Role of Carnosine in Combination With Vitamin B Complex in Preventing the Progression of Diabetic Neuropathy in Type 2 Diabetes Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Beni-Suef University
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Neopterin biomarker
Study Overview
Brief Summary
Evaluation of the influence of oral administration of carnosine in combination with vitamin B Complex in preventing the progression of diabetic neuropathy in type 2 diabetes patients.
Detailed Description
Diabetic peripheral neuropathy (DPN) is considered the most common chronic complication of diabetes mellitus, with an incidence rate of about 50%.
DPN is a group of clinical syndromes that affects single or combined regions in the nervous system and is considered one of the microvascular complications that affect greatly the quality of life of patients due to pain and frequency of hospitalization.
DPN commonly develops silent without symptoms in the early stages and when symptoms start appearing only a few effective therapies are available and that is what causes significant patient suffering and societal burden.
Those mechanisms of pain and treatment remain challenging and are restricted by variable efficacy and side effects of therapies and intensification of glycemic control remain the cornerstone for the prevention or delay of DPN.
Lately, it has been proven that long-term low-grade inflammation has an important role in DPN pathogenesis. Clinical trials in DPN patients with pain and without pain showed that the DPN with pain group had higher inflammation markers.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Masking Description
intervention clinical trial
Eligibility Criteria
- Ages
- 20 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Type 2 diabetes Patients as per ADA criteria.
- •Patients were showing clinical signs of Diabetic neuropathy verified by a neurologist and confirmed by a score ≥7 on the MNSI questionnaire (Michigan Neuropathy Screening Instrument), with abnormal nerve conduction measurement.
- •Patients on a regular visit to the clinic.
Exclusion Criteria
- •Patients with neuropathy of non-diabetic origin were excluded.
- •Patients with a BMI of 40 kg/m2 or more and those pregnant or breastfeeding were also excluded
Outcomes
Primary Outcomes
Neopterin biomarker
Time Frame: 3 months
Neopterin, a marker of inflammation and cellular immune response, is elevated in conditions of T-cell or macrophages activation. Diabetic peripheral neuropathy (DPN) is associated with inflammatory/immune processes therefore Investigators hypothesized that it will decrease after intervention
malondialdehyde biomarker
Time Frame: 3 months
it is oxidative stress marker that increases in the lipid peroxidation and inflammation happening during diabetic neuropathy and investigators hypothesized that it will decrease after intervention
Nerve Growth Factor
Time Frame: 3 months
a neurotrophic factor and neuropeptide primarily involved in the regulation of growth, maintenance, proliferation, and survival of certain target neurons and investigathypothesized its increase after intervention
Secondary Outcomes
No secondary outcomes reported
Investigators
Mahitab Hany Ahmed
Principle investigator (Assistant lecturer of clinical pharmacy department )
Beni-Suef University