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

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000002
• Date of registration: 27/02/2009
• Primary sponsor: Center of Pharmaceutical Chemistry
• Public title: Effect of the supplementation with Vimang ® on indicators of oxidative stress in young people with Diabetes Mellitus type 1.
• Scientific title: Effect of the supplementation with Vimang ® on indicators of oxidative stress in young people with Diabetes Mellitus type 1.
• Date of first enrolment: 15/01/2008
• Target sample size: 50 patients
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000002-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Double Blind Placebo: Placebo Assignment: Parallel Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Dr. Alina Alvarez-Leon
• Affiliation: Center of Pharmaceutical Chemistry

• Name: Dr. Alina Alvarez-Leon
• Affiliation: Center of Pharmaceutical Chemistry

Key inclusion & exclusion criteria

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.

Age minimum: 15 years old
Age maximum: 25 years old
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetes mellitus Type 1

Intervention(s)

The treatment will be applied orally, according to the following outline: Group 1: Vimang®, 1 pill of 300 mg 3 times a day during 6 months plus the habitual therapy for the diabetes, the diet and the exercises. Group 2: Placebo, 1 pill of 300 mg 3 times a day during 6 months plus the habitual therapy for the diabetes, the diet and the exercises.

Primary Outcome(s)

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(s)

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.

Source(s) of Monetary Support

Ministry of Public Health, (MINSAP) and Ministry of Science, Technology and Environment (CITMA).