Role of Carnosine in Combination With Vitamin B Complex in Preventing the Progression of Diabetic Neuropathy in Type 2 Diabetes Patients

What Was Tested

The trial (not phased) is built around Carnosine.

It had two arms (groups): intervention Group (experimental) and Control group (no intervention).

Patients who will receive carnosine supplementation + Vitamin B complex two tablets per day.

Patients will receive only Vitamin B Complex two tablets per day.

The registry classes the interventions as dietary supplement.

More on the Plan

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.

Lately, it has been proven that long-term low-grade inflammation has an important role in DPN pathogenesis.

Besides the correlation between abnormalities in nerve fibers and the rise in interleukin (IL)-6 and IL-10.

Those reactive oxygen species are capable of destroying the lipids found in the myelinated structures of nerves resulting in axon loss and disturbance in the microvasculature of the peripheral nervous system.

Who Took Part

Enrollment: 60 actual participants took part.

It was open to people of any sex aged from 20 years up to 100 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Type 2 diabetes Patients as per ADA criteria. Patients on a regular visit to the clinic.

The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Carnosine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Carnosine group and the comparison group ran side by side rather than switching.

Being open-label, the Carnosine study did not mask who received what.

It started in 2021-01-14 with completion listed for 2022-01-30.

It ran at 1 site in Egypt.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Neopterin biomarker (time frame: 3 months). malondialdehyde biomarker (time frame: 3 months). Nerve Growth Factor (time frame: 3 months).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Carnosine in 60 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Carnosine compound page, all human trials.