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Dietetic Intervention With Soluble Fiber in Type 2 Diabetes Mellitus (DM) Patients With Metabolic Syndrome (MS)

H

Hospital de Clinicas de Porto Alegre

Status

Completed

Conditions

Albuminuria
Metabolic Syndrome

Treatments

Dietary Supplement: guar gum

Study type

Interventional

Funder types

Other

Identifiers

NCT01071785
HCPA-06370

Details and patient eligibility

About

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.

Full description

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.

Enrollment

42 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with type 2 diabetes
  • Using metformin and/or Insulin

Exclusion criteria

  • serum triglycerides > 400 mg/dl
  • serum creatinine > 2 mg/dl
  • gastrointestinal malabsorption

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

42 participants in 2 patient groups

usual diet
No Intervention group
Description:
no dietary or drug intervention. Patients followed their usual diet.
guar gum
Experimental group
Description:
guar gum
Treatment:
Dietary Supplement: guar gum

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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