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 |
| Secondary identifying numbers | 2005-785-022 |
- 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
Scientific
Ave Cuauhutemoc 330
Colonia Doctores
Mexico Distrito Federal
06720
Mexico
| Phone | +52 55627690 ext.21507 or 21481 |
|---|---|
| susanacast@usa.net |
Study information
| Study design | Randomized, double-blind, clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 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 study start date | 28/11/2005 |
| Completion date | 30/11/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
06720
Mexico
Sponsor information
Mexican Institute of Social Security (Instituto Mexicano del Seguro Social) (Mexico)
Government
Government
Ave Cuauhutemoc 330
Colonia Doctores
Mexico Distrito Federal
06720
Mexico
| Phone | +55 56276900 ext 21963 |
|---|---|
| mdelpradom@cis.gob | |
| Website | http://www.cis.gob.mx |
"ROR" |
https://ror.org/03xddgg98 |
Funders
Funder type
Government
Mexican Institute of Social Security (Instituto Mexicano del Seguro Social)
No information available
Fabrica de Galletas la Moderna
No information available
Laboratorio Silanes
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
