Effect of a dietary fiber and magnesium supplement on endothelial dysfunction, inflammation and glycemic control markers in patients with type 2 diabetes mellitus. Randomized, double-blind clinical trial.

ISRCTN	ISRCTN40918692
DOI	https://doi.org/10.1186/ISRCTN40918692
Protocol serial number	2005-785-022
Sponsor	Mexican Institute of Social Security (Instituto Mexicano del Seguro Social) (Mexico)
Funders	Mexican Institute of Social Security (Instituto Mexicano del Seguro Social), Fabrica de Galletas la Moderna, Laboratorio Silanes

Submission date: 01/05/2006
Registration date: 30/06/2006
Last edited: 30/06/2006

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Susana Castanon
Scientific

Ave Cuauhutemoc 330
Colonia Doctores
Mexico Distrito Federal
06720
Mexico

Phone	+52 55627690 ext.21507 or 21481
Email	susanacast@usa.net

Study information

Primary study design	Interventional
Study design	Randomized, double-blind, clinical trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Biomarkers of endothelial dysfunction (selectin 2, vascular cell adhesion molecules [vcam]) and intercellular adhesion molecule [icam])
Key secondary outcome measure(s)	1. Serum levels of inflammation markers (interleukin-6, C-reactive protein) 2. Plasma levels of glycemic control markers (glycated hemoglobin and glucose)
Completion date	30/11/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	400
Key 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
Key exclusion criteria	1. Clinical evidence of chronic complications at the time of enrolment 2. Chronic diarrhea 3. Renal function impairment
Date of first enrolment	28/11/2005
Date of final enrolment	30/11/2006

Locations

Countries of recruitment

Mexico

Study participating centre

Ave Cuauhutemoc 330

Mexico Distrito Federal
06720
Mexico

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan