Diabetes Mellitus Type 2 Clinical Trial
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
Verified date | February 2017 |
Source | Hospital de Clinicas de Porto Alegre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 19 |
Est. completion date | January 2017 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital de Clínicas de Porto Alegre | Porto Alegre | Rio Grande do Sul |
Lead Sponsor | Collaborator |
---|---|
Hospital de Clinicas de Porto Alegre | Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Federal University of Rio Grande do Sul |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Area Under the Curve (AUC 0-180min) for glycemic and insulinemic responses | Prior to the initial meal A, B and C and 30, 60,120,180 minutes postmeal |
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