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

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General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Source(s) of monetary or material support:

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

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of the Quality of Drugs(CECMED)

Authorization date :

07/05/2008

Reference number:

Volume 06, Folio 000289, N 768/05.001.07.N.

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Dr. Manuel Vera-Gonzalez

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

Country:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

None

Research ethics committees:

Ethics Committe of National Institute of Endocrinology Date: 18/09/06

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

15/01/2008

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

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.

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

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.

Key secondary outcomes:

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.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

15 years old

Maximum age:

25 years old

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.

Type of population:

Children and Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

2

Target sample size:

50 patients

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Dr. Alina

Last Name:

Alvarez-Leon

Affiliation:

Center of Pharmaceutical Chemistry

Postal Address:

21 Ave. and 200 St. Atabey, Playa.

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

(537) 271 5067

Email :

alina.alvarez@infomed.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Dr. Alina

Last Name:

Alvarez-Leon

Affiliation:

Center of Pharmaceutical Chemistry

Postal Address:

21 ave. and 200 St. Atabey, Playa.

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

(537) 271 5067

Email :

alina.alvarez@infomed.sld.cu

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000002

Date of Registration in Primary Registry:

2009-02-27

Record Verification Date:

2009-02-11 19:00

Link to the spanish version:

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

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