Condition category
Nutritional, Metabolic, Endocrine
Date applied
01/05/2006
Date assigned
30/06/2006
Last edited
30/06/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Susana Castanon

ORCID ID

Contact details

Ave Cuauhutemoc 330
Colonia Doctores
Mexico Distrito Federal
06720
Mexico
+52 55627690 ext.21507 or 21481
susanacast@usa.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2005-785-022

Study information

Scientific title

Acronym

Study hypothesis

Biomarkers of endothelial dysfunction (selectin 2, vascular cell adhesion molecules [vcam], and intercellular adhesion molecule [icam]) will be lower in the patients with dietary fiber and magnesium supplements than those without them.

Ethics approval

The name of the ethical committee that gave approval for the trial is Ethics Subcommittee of the National Commission for Scientific Research, Institute of Mexican Social Security (Comisión Nacional de Investigación Científica, Subcomité de Ética, Instituto Mexicano del Seguro Social), 14/04/2005; reference number: 09-B5-61-2800/983 2005-785-022

Study design

Randomized, double-blind, clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Diabetes mellitus type 2

Intervention

There are four arms of treatment. All four groups received the best therapy available to control dm2 which include the ADA nutrition treatment guidelines. There was a nutritionist that gave specific suggestions according to each patient's needs, with an indication of losing weight if necessary. All patients received oral hypoglycaemic products and antihypertensive therapy as much as was needed to achieve the target levels of glucose and blood pressure. Patients were randomised to receive one of the following interventions:
1. Active cookies and active tablets
2. Combination of placebo and active cookies
3. Combination of placebo and active tablets
4. Control group: placebo cookies and placebo tablets

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Biomarkers of endothelial dysfunction (selectin 2, vascular cell adhesion molecules [vcam]) and intercellular adhesion molecule [icam])

Secondary outcome measures

1. Serum levels of inflammation markers (interleukin-6, C-reactive protein)
2. Plasma levels of glycemic control markers (glycated hemoglobin and glucose)

Overall trial start date

28/11/2005

Overall trial end date

30/11/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Having diabetes mellitus type 2 (dm2) according to the American Diabetes Association (ADA) criteria
2. Male or female
3. Up to 48 months of dm2 diagnosis
4. Aged 30-70 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

Participant exclusion criteria

1. Clinical evidence of chronic complications at the time of enrolment
2. Chronic diarrhea
3. Renal function impairment

Recruitment start date

28/11/2005

Recruitment end date

30/11/2006

Locations

Countries of recruitment

Mexico

Trial participating centre

Ave Cuauhutemoc 330
Mexico Distrito Federal
06720
Mexico

Sponsor information

Organisation

Mexican Institute of Social Security (Instituto Mexicano del Seguro Social) (Mexico)

Sponsor details

Ave Cuauhutemoc 330
Colonia Doctores
Mexico Distrito Federal
06720
Mexico
+55 56276900 ext 21963
mdelpradom@cis.gob

Sponsor type

Government

Website

http://www.cis.gob.mx

Funders

Funder type

Government

Funder name

Mexican Institute of Social Security (Instituto Mexicano del Seguro Social)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Fabrica de Galletas la Moderna

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Laboratorio Silanes

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes