Evaluation of Fats on Postprandial Glucose Control (Nabucco)
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Different fat types
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes
Eligibility Criteria
Inclusion Criteria:
- Adult patients (aged 18-75 years) with type 1 diabetes > 3 years.
- On insulin pump therapy.
- A1c < 8.5%.
Exclusion Criteria:
- History or symptoms suggestive of gastric dysmotility, celiac disease, pancreatic exocrine dysfunction or other conditions that cause malabsorption or maldigestion.
- Eating disorder.
- Diet allergies.
- Special diet restrictions, such as vegan or any nut allergy.
- Medications know to affect insulin sensitivity (such as glucocorticoids) or affect gastrointestinal motility (such as reglan).
- High-titre insulin autoantibodies with delayed insulin kinetics.
- Women who are breast feeding, pregnant, or wanting to become pregnant.
Sites / Locations
- Joslin Diabetes Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Meal challenge
Arm Description
Different fat types
Outcomes
Primary Outcome Measures
Area under the curve (AUC)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01869790
First Posted
June 2, 2013
Last Updated
April 25, 2017
Sponsor
Joslin Diabetes Center
Collaborators
Boston Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01869790
Brief Title
Evaluation of Fats on Postprandial Glucose Control
Acronym
Nabucco
Official Title
Development of "Fat" Bolus for Coverage of Higher Fat Meals.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Joslin Diabetes Center
Collaborators
Boston Children's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Meal challenge
Arm Type
Experimental
Arm Description
Different fat types
Intervention Type
Other
Intervention Name(s)
Different fat types
Intervention Description
Saturated, monounsaturated fats
Primary Outcome Measure Information:
Title
Area under the curve (AUC)
Description
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.
Time Frame
0-180 minutes vs 180-360 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients (aged 18-75 years) with type 1 diabetes > 3 years.
On insulin pump therapy.
A1c < 8.5%.
Exclusion Criteria:
History or symptoms suggestive of gastric dysmotility, celiac disease, pancreatic exocrine dysfunction or other conditions that cause malabsorption or maldigestion.
Eating disorder.
Diet allergies.
Special diet restrictions, such as vegan or any nut allergy.
Medications know to affect insulin sensitivity (such as glucocorticoids) or affect gastrointestinal motility (such as reglan).
High-titre insulin autoantibodies with delayed insulin kinetics.
Women who are breast feeding, pregnant, or wanting to become pregnant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard Wolpert, MD
Organizational Affiliation
Joslin Diabetes Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Joslin Diabetes Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluation of Fats on Postprandial Glucose Control
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