Glycemic and Satiety Response to Fiber and Glycemic Index of Meals in Diabetes
| Tracking Information | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | August 3, 2011 | ||||||||||||||||
| Last Updated Date | August 4, 2011 | ||||||||||||||||
| Start Date ICMJE | March 2011 | ||||||||||||||||
| Estimated Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||||||||||||||
| Current Primary Outcome Measures ICMJE |
glycemic control [ Time Frame: fasting and post-prandial (differents times during 180 minutes) ] [ Designated as safety issue: Yes ] glucose and insulin |
||||||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Change History | Complete list of historical versions of study NCT01410292 on ClinicalTrials.gov Archive Site | ||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
measures of satiety and appetite [ Time Frame: fasting and post-prandial (different times for 180 min) ] [ Designated as safety issue: Yes ] ghrelin and subjective analogue scale of appetite |
||||||||||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Descriptive Information | |||||||||||||||||
| Brief Title ICMJE | Glycemic and Satiety Response to Fiber and Glycemic Index of Meals in Diabetes | ||||||||||||||||
| Official Title ICMJE | Glycemic and Satiety Response to Meals With Different Fiber Content and Glycemic Index in Type 2 Diabetic Patients | ||||||||||||||||
| 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. |
||||||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||||||
| Study Phase | Not Provided | ||||||||||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Subject) |
||||||||||||||||
| Condition ICMJE | Type 2 Diabetes Mellitus | ||||||||||||||||
| Intervention ICMJE |
|
||||||||||||||||
| Study Arm (s) |
|
||||||||||||||||
| Publications * | Not Provided | ||||||||||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||||||||||
| Recruitment Information | |||||||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||||||
| Estimated Enrollment ICMJE | 20 | ||||||||||||||||
| Estimated Completion Date | January 2012 | ||||||||||||||||
| Estimated Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||||||||||
| Gender | Both | ||||||||||||||||
| Ages | 18 Years to 80 Years | ||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||
| Contacts ICMJE |
|
||||||||||||||||
| Location Countries ICMJE | Brazil | ||||||||||||||||
| Administrative Information | |||||||||||||||||
| NCT Number ICMJE | NCT01410292 | ||||||||||||||||
| Other Study ID Numbers ICMJE | GPPG 10-0472 | ||||||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||||||
| Responsible Party | Mirela Jobim de Azevedo, Endocrine Division of Hospital de Clínicas de Porto Alegre | ||||||||||||||||
| Study Sponsor ICMJE | Hospital de Clinicas de Porto Alegre | ||||||||||||||||
| Collaborators ICMJE |
|
||||||||||||||||
| Investigators ICMJE |
|
||||||||||||||||
| Information Provided By | Hospital de Clinicas de Porto Alegre | ||||||||||||||||
| Verification Date | August 2011 | ||||||||||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||||||||||