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Glycemic and Satiety Response to Fiber and Glycemic Index of Meals in Diabetes

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2011 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01410292
First Posted: August 5, 2011
Last Update Posted: August 5, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Federal University of Rio Grande do Sul
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by:
Hospital de Clinicas de Porto Alegre
  Purpose
The aim of this study is to assess the post-prandial response of four breakfast with different content of dietary fiber and glycemic index on glycemic response and satiety in patients with type 2 diabetes.

Condition Intervention
Type 2 Diabetes Mellitus Other: GI and fiber meals Other: meals

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Official Title: Glycemic and Satiety Response to Meals With Different Fiber Content and Glycemic Index in Type 2 Diabetic Patients

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • glycemic control [ Time Frame: fasting and post-prandial (differents times during 180 minutes) ]
    glucose and insulin


Secondary Outcome Measures:
  • measures of satiety and appetite [ Time Frame: fasting and post-prandial (different times for 180 min) ]
    ghrelin and subjective analogue scale of appetite


Estimated Enrollment: 20
Study Start Date: March 2011
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: meal D
low fiber and low GI
Other: GI and fiber meals
meals with different fiber content and glycemic index
Other: meals
four different meal regarding GI and fiber content
Experimental: meal C
low Fiber and High GI
Other: GI and fiber meals
meals with different fiber content and glycemic index
Other: meals
four different meal regarding GI and fiber content
Experimental: meal B
high Fiber and low GI
Other: GI and fiber meals
meals with different fiber content and glycemic index
Other: meals
four different meal regarding GI and fiber content
Experimental: meal A
high fiber and high GI meal
Other: GI and fiber meals
meals with different fiber content and glycemic index
Other: meals
four different meal regarding GI and fiber content

Detailed Description:

Design study:

Single-blind crossover randomized clinical trial

Hypothesis:

A meal with high GI and high fiber content determines a lower glycemic response compared to a meal with high GI and low fiber content (fiber beneficial effect on glycemic response independent of glycemic index.

Test meals:

Four test meals isocaloric and with the same proportion of macronutrients will be evaluated (5 kcal/kg, 17% of energy provided by protein, 58% of energy provided by carbohydrates, and 25% of energy provided by fat):

Test Meal A:high glycemic index (GI= 60.3%) and high fiber content(5.88g) Test Meal B:high glycemic index (GI= 62.8%) and LOW fiber content(2.05g) Test Meal C:low glycemic index (GI= 37.0%) and high fiber content(5.75g) Test Meal D:low glycemic index (GI= 38.4%) and high fiber content(1.91g)

Outcomes:

Glycemic response: serum glucose and insulin Satiety response: serum ghrelin and subjective assessment of satiety by a specific scale for measurement of appetite in single test meal studies.

Logistic:

Patients will undergo a clinical, nutritional and laboratory evaluation for confirm the inclusion criteria and will be request to give their written informed consent.

All participants will test each meal with a mean of seven days separating the individual test days.A 12h fast will precede all the study visits.Pre-and postprandial blood samples will be draw to determine the concentrations of serum insulin and plasma glucose, and ghrelin through an antecubital cannula before and 15, 30, 45, 60, 90, 120 and 180 min after the test meals. The VAS scale will be applied in these times.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • type 2 diabetes,
  • HbA1c < 9%,
  • BMI < 35kg/m²,
  • Metformin and/or diet as treatment for diabetes

Exclusion Criteria:

  • Use of insulin as diabetes treatment
  • digestive disease with malabsorption
  • diabetes neuropathy with gastroparesis
  Contacts and Locations
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): NCT01410292


Contacts
Contact: Flávia M Silva 93771824 flavia.moraes.silva@hotmail.com

Locations
Brazil
Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Contact: Flávia M Silva    93771824    flavia.moraes.silva@hotmail.com   
Sub-Investigator: Thais Steemburgo         
Sub-Investigator: Caroline Kramer         
Sub-Investigator: Giovana Menegotto         
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
Study Chair: Flávia M Silva Hospital de Clínicas de Porto Alegre
Study Chair: Thais Steemburgo Hospital de Clínicas de Porto Alegre
Study Chair: Caroline Kramer Hospital de Clínicas de Porto Alegre
Study Chair: Giovana Menegotto Hospital de Clínicas de Porto Alegre
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mirela Jobim de Azevedo, Endocrine Division of Hospital de Clínicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT01410292     History of Changes
Other Study ID Numbers: GPPG 10-0472
First Submitted: August 3, 2011
First Posted: August 5, 2011
Last Update Posted: August 5, 2011
Last Verified: August 2011

Keywords provided by Hospital de Clinicas de Porto Alegre:
fiber
glycemic index
glycemic response
diabetes
ghrelin

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