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

Primary Purpose

Metabolic Syndrome, Albuminuria

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
guar gum
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome focused on measuring Metabolic Syndrome, diet, fiber, Serum lipids, Albuminuria

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • HCPA

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

usual diet

guar gum

Arm Description

no dietary or drug intervention. Patients followed their usual diet.

guar gum

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

changes on serum fatty acids and serum cholesterol

Full Information

First Posted
June 6, 2008
Last Updated
February 25, 2010
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT01071785
Brief Title
Dietetic Intervention With Soluble Fiber in Type 2 Diabetes Mellitus (DM) Patients With Metabolic Syndrome (MS)
Official Title
Dietetic Intervention With Soluble Fiber in Type 2 Diabetes Mellitus (DM) Patients With Metabolic Syndrome (MS)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Albuminuria
Keywords
Metabolic Syndrome, diet, fiber, Serum lipids, Albuminuria

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
usual diet
Arm Type
No Intervention
Arm Description
no dietary or drug intervention. Patients followed their usual diet.
Arm Title
guar gum
Arm Type
Experimental
Arm Description
guar gum
Intervention Type
Dietary Supplement
Intervention Name(s)
guar gum
Other Intervention Name(s)
benefiber; guar gum group
Intervention Description
guar gum 10g/day for six weeks
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
changes on serum fatty acids and serum cholesterol
Time Frame
4 and 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mirela J Azevedo, MD
Organizational Affiliation
HCPA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jorge L Gross, MD
Organizational Affiliation
HCPA
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Valesca Dall'Alba, RD
Organizational Affiliation
HCPA
Official's Role
Principal Investigator
Facility Information:
Facility Name
HCPA
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90630040
Country
Brazil

12. IPD Sharing Statement

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

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