Clinical trial NCT01410292: Glycemic and Satiety Response to Fiber and Glycemic Index of Meals in Diabetes
Official title: Glycemic and Satiety Response to Meals With Different Fiber Content and Glycemic Index in Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: fiber
glycemic index
glycemic response
diabetes
ghrelin
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Federal University of Rio Grande do Sul
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2011-08-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: 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.

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 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

Primary outcomes:
measure: glycemic control
timeFrame: fasting and post-prandial (differents times during 180 minutes)
Secondary outcomes:
measure: measures of satiety and appetite
timeFrame: fasting and post-prandial (different times for 180 min)
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Flávia M Silva
role: STUDY_CHAIR
affiliation: Hospital de Clínicas de Porto Alegre
name: Thais Steemburgo
role: STUDY_CHAIR
affiliation: Hospital de Clínicas de Porto Alegre
name: Caroline Kramer
role: STUDY_CHAIR
affiliation: Hospital de Clínicas de Porto Alegre
name: Giovana Menegotto
role: STUDY_CHAIR
References:
citation: Silva FM, Kramer CK, Crispim D, Azevedo MJ. A high-glycemic index, low-fiber breakfast affects the postprandial plasma glucose, insulin, and ghrelin responses of patients with type 2 diabetes in a randomized clinical trial. J Nutr. 2015 Apr;145(4):736-41. doi: 10.3945/jn.114.195339. Epub 2015 Feb 11.