Dietetic Intervention With Soluble Fiber in Type 2 Diabetes Mellitus (DM) Patients With Metabolic Syndrome (MS)
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|ClinicalTrials.gov Identifier: NCT01071785|
Recruitment Status : Completed
First Posted : February 19, 2010
Last Update Posted : March 1, 2010
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome Albuminuria||Dietary Supplement: guar gum||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dietetic Intervention With Soluble Fiber in Type 2 Diabetes Mellitus (DM) Patients With Metabolic Syndrome (MS)|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||December 2009|
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
- 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 ]
- changes on serum fatty acids and serum cholesterol [ Time Frame: 4 and 6 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|