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Trial record 72 of 1010 for:    Area Under Curve AND insulin

Glycemic and Insulinemic Response With Different Sources of Soluble Fiber in Patients Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT02204384
Recruitment Status : Completed
First Posted : July 30, 2014
Last Update Posted : February 14, 2017
Sponsor:
Collaborators:
Federal University of Rio Grande do Sul
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by (Responsible Party):
Mirela Jobim de Azevedo, Hospital de Clinicas de Porto Alegre

Brief Summary:
To compare the acute effect of soluble fiber intake from foods or supplement after a common meal on postprandial plasma glucose and insulin in patients with type 2 diabetes. The hypothesis is a meal with a high content of soluble fiber from food determines glycemic and insulinemic response similar to a meal with a high content of soluble fiber from supplement sources.

Condition or disease Intervention/treatment Phase
Dietary Modification Diabetes Mellitus Type 2 Insulin Tolerance Diabetic Blood Glucose Monitoring Other: HFD Meal: High fiber from food Dietary Supplement: HFS Meal: High fiber from supplement Other: UF Meal: usual amount of fiber Not Applicable

Detailed Description:
Three breakfasts (high amount of fiber from diet food sources - HFD, high amount of soluble fiber from guar gum supplement - HFS and usual amount of fiber -UF), isocaloric and similar distribution of carbohydrates, proteins and lipids, the order of breakfasts randomly determined. Meals HFD and HFS have the same amount of fiber from different sources, origin in food and supplement respectively. Meal UF consist of the same foods meal HFS, but without the use of soluble fiber supplement and white bread instead of rye bread (low fiber content in relation to meals HFD and HFS). The supplement (Sachet 5g - Fiber Mais ®: 60% guar gum and 40% inulin) will be added to the plain water to meal HFD.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Plasma Glucose and Insulin Responses After Consumption of Breakfasts With Different Sources of Soluble Fiber in Type 2 Diabetes Patients: a Randomized Crossover Clinical Trial
Study Start Date : August 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HFD Meal: high fiber from food
HFD Meal: high amount of fiber from diet food sources (total fiber 9.7g; soluble fiber 5.4g)
Other: HFD Meal: High fiber from food
High amount of fiber from diet food sources (HFD; total fiber 9.7g; soluble fiber 5.4g)
Other Name: HFD

Experimental: HFS Meal: High fiber from supplement
HFS Meal: high amount of soluble fiber from guar gum supplement (HFS; total fiber 9.1g; soluble fiber 5.4g) - Fiber Mais, Nestlé
Dietary Supplement: HFS Meal: High fiber from supplement
High amount of soluble fiber from guar gum supplement (HFS; total fiber 9.1g; soluble fiber 5.4g) - sachet 5 g Fiber Mais, Nestlé Brasil, São Paulo, BR
Other Name: HFS

Experimental: UF Meal: usual amount of fiber
UF Meal: usual amount of fiber (total fiber 2.4g; soluble fiber 0.8g)
Other: UF Meal: usual amount of fiber
Usual amount of fiber (UF; total fiber 2.4g; soluble fiber 0.8g)




Primary Outcome Measures :
  1. Area Under the Curve (AUC 0-180min) for glycemic and insulinemic responses [ Time Frame: Prior to the initial meal A, B and C and 30, 60,120,180 minutes postmeal ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with type 2 diabetes
  • Body Mass Index (BMI) <= 35 kg / m²
  • Hemoglobin A1c (HbA1c) <= 9%

Exclusion Criteria:

  • Serum creatinine >2.0 mg/dL
  • Digestive diseases (e.g. malabsorption)
  • Severe autonomic neuropathy (presence of symptomatic postural hypotension, gastroparesis, diabetic diarrhea)
  • Recent cardiovascular event
  • Cachexia
  • Psychiatric disorder with impairment of understanding
  • Participating in other research protocol

Information from the National Library of Medicine

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): NCT02204384


Locations
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Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Federal University of Rio Grande do Sul
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Investigators
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Principal Investigator: Mirela J Azevedo, PhD Hospital de Clínicas de Porto Alegre

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mirela Jobim de Azevedo, PhD, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT02204384     History of Changes
Other Study ID Numbers: 140161
First Posted: July 30, 2014    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Mirela Jobim de Azevedo, Hospital de Clinicas de Porto Alegre:
Dietary fiber
Dietary Supplements
Type 2 diabetes
Postprandial Period
Plasma insulin
Plasma glucose
Area Under Curve
Soluble fiber

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases