Effect of the supplementation with Vimang ® on indicators of oxidative stress in young people with Diabetes Mellitus type 1.

Phase 2

• Conditions: Diabetes mellitus Type 1; Diabetes Mellitus, Type 1; Oxidative Stress; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Metabolism

• Registration Number: RPCEC00000002
• Lead Sponsor: Center of Pharmaceutical Chemistry

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Young patients of both sexes who are attended in ambulatory clinics, with diagnosis of diabetes mellitus type 1. - Time of evolution of the diabetes smaller than 10 years. - Patients that have values of glicosilated hemoglobin smaller than 8,0%. - Patients that sign the Informed Consent.

Exclusion Criteria

- Pregnancy and nursing. - The presence of chronic illnesses associated to the oxidative stress not related with the diabetes (hypertension, asthma, autoimmune illnesses and stroke). - Patiens with regularly alcohol consumption - Patients that not fulfil the inclusion criteria. - Patient that participate in another clinical trial with antioxidants. - The use of some antioxidant those are indispensable for the treatment of chronic illnesses for the patient (Captopril, Vitamin E, Vitamin C, Aminopirina, Dipiridamol). - The oligoelements ingestion or vitamins and minerals 2 weeks before beginning the treatment for the patient. - The patient's negative to introduce the established dose of the Vimang®. - The patient's negative to carry out the protocolized investigations. - Patient that not fulfil with the measures of systematic control.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Global indicator: Perioxidation Potential (PP): Value of reference: 7,32 + - 0,56 uM,it will consider positive answer when the final value of PP diminishes in at least an unit (final value - initial value). This result will be in correspondence with the mean of the peroxidation potential (PP) and its decrease in 1.5 times of the group of diabetic treated with extract of the bark of Mangifera L. indicates (Vimang®) with regard to the group that is administered placebo, in the one that the variation in an unit corresponds it previously described, according to the used statistical program. This variable will be measured to the beginning, to the 3 months of initiate the treatment and to the 6 months.

Secondary Outcome Measures

Name	Time	Method
Improvement of anyone of the following variables: that is to say that the values are included in the non diabetics' reference interval or diabetics with good glucemic control Enzymes: Superoxide dismutasa (SOD): Value of reference: 1,45 + - 0,15 /mL/min Catalase (CAT):value of reference: 161,5 + - 12,5 or / L/min CAT/SOD: value of reference: 0,11 + - 0,02 Biomolecular damage: MDA: Value of reference: 1,74 + - 0,27u Hydroperoxides (ROOH): Value of reference: 103 + - 17uM Advanced products of the oxidation of proteins (APOP): Value of reference: 12,13 + - 0,93uM In leukocytes: Fragmentation of the DNA Low molecular weight antioxidant. Glutation reduced (GSH): Value of reference: 786-1156 mg/L These variables will be measured to the beginning, to the 3 months of initiate treatment and the 6 months.