Dietetic Intervention With Soluble Fiber in Type 2 Diabetes Mellitus (DM) Patients With Metabolic Syndrome (MS)
Metabolic Syndrome (MS) is an clinical condition with high cardiovascular risk. More than 80% of DM patients had MS. Dietary factors can be associated to both, DM and MS. Therefore the aim of this study is to evaluate the effects of add soluble fiber (goma-guar) in the usual diet of type 2 DM with MS and compare this intervention with an usual diet without this supplement.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Dietetic Intervention With Soluble Fiber in Type 2 Diabetes Mellitus (DM) Patients With Metabolic Syndrome (MS)|
- Changes on the components of metabolic syndrome (according to IDF and WHO criteria): blood pressure, waist, body mass index (BMI), triglycerides, high-density lipoprotein (HDL) cholesterol, glucose values (HBA1c) and urinary albumin excretion. [ Time Frame: 4 and 6 weeks ] [ Designated as safety issue: No ]
- changes on serum fatty acids and serum cholesterol [ Time Frame: 4 and 6 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||June 2007|
|Study Completion Date:||December 2009|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
No Intervention: usual diet
no dietary or drug intervention. Patients followed their usual diet.
Experimental: guar gum
Dietary Supplement: guar gum
guar gum 10g/day for six weeks
Other Name: benefiber; guar gum group
The aim of this study was to evaluate the effect of soluble fiber (guar gum) on the MS components (International Diabetes Federation-2005 and WHO): blood pressure, plasma glucose, triglycerides, HDL, central obesity (waist, BMI),and albuminuria. Secondary objectives are: effect of guar gum on serum fatty acids, , PCR, endothelin 1, and fibrinogen. Primary outcomes were alterations on MS components.
Forty-four type 2 diabetic outpatients were included in a randomized clinical trial: treatment 1- guar gum (10g/day) + usual diet; treatment 2- usual diet. The duration of each treatment was six weeks. Three days weight diet records with concurrent 24h urinary collections (protein intake estimative), clinical and laboratory evaluation were performed at baseline and after 4 and 6 weeks. Serum fatty acids were measured in total triglycerides fractions by gas chromatography.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01071785
|Porto Alegre, RS, Brazil, 90630040|
|Principal Investigator:||Mirela J Azevedo, MD||HCPA|
|Study Director:||Jorge L Gross, MD||HCPA|
|Principal Investigator:||Valesca Dall'Alba, RD||HCPA|