Evaluation of Fats on Postprandial Glucose Control (Nabucco)
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|ClinicalTrials.gov Identifier: NCT01869790|
Recruitment Status : Completed
First Posted : June 5, 2013
Last Update Posted : April 26, 2017
The purpose of this study is examine the effect of different fat types on postprandial glucose control in patients with type 1 diabetes.
Subjects will have several admissions and, in random order, will receive lunches with identical carbohydrate content but different fat content: lunch A will minimal fat content, lunch B will contain added butter, lunch C will contain added olive oil, and lunch D will contain added cheese. Total fat content in lunches B-D will be the same. Subjects will receive identical insulin doses (calculated using the subject's usual insulin-to-carbohydrate ratio) for the meals.
The investigators hypothesize that, despite identical carbohydrate content,the lunches higher in saturated fat will lead to more postprandial hyperglycemia than the lunch containing minimal fat and the lunch high in monounsaturated fat.
The hypothesis is that from time points 0-180 minute area under the curve for Lunches A, B, C, and D will be the same, whereas from time points 180-360 minutes for Lunch B and D will be greater than that of Lunch A and C.
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Other: Different fat types||Not Applicable|
Subjects for this study will be adults with type 1 diabetes who use insulin pump in their diabetes self-management. Prior to admission the the clinical research center the basal rates and insulin-to-carbohydrate ratio of the subjects will be optimized using standard clinical procedures.
Subjects will be admitted to the clinical research center in mid-morning following a light breakfast at home. Subjects will have several admissions and, in random order, will receive lunches with identical carbohydrate content but different fat content: lunch A will minimal fat content, lunch B will contain added butter, lunch C will contain added olive oil, and lunch D will contain added cheese. Total fat content in lunches B-D will be the same. Subjects will receive identical insulin doses (calculated using the subject's usual insulin-to-carbohydrate ratio) for the meals. Blood samples for measurement of plasma glucose and insulin levels will be drawn for the subsequent 6 hours. We hypothesize that postprandial glucose levels 3-6 hours after start of the meal will be higher following lunches B and D, compared to lunches A and C.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Development of "Fat" Bolus for Coverage of Higher Fat Meals.|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||April 2015|
Experimental: Meal challenge
Different fat types
Other: Different fat types
Saturated, monounsaturated fats
- Area under the curve (AUC) [ Time Frame: 0-180 minutes vs 180-360 minutes ]One-way repeated measures ANOVA will be used to analyze area under curve differences between the three lunches as well as time in target range (80-180 mg/dL), peak blood glucose, time to peak blood glucose, time to return to baseline blood glucose.
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): NCT01869790
|United States, Massachusetts|
|Joslin Diabetes Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Howard Wolpert, MD||Joslin Diabetes Center|