Back to resultsEffect of Dietary Fat on Glycemic Control in Type 1 Diabetes
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High fat meal
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes
Eligibility Criteria
Inclusion Criteria:
- type 1 diabetes using insulin pump and CGM
Exclusion Criteria:
- renal or hepatic failure
- cancer or lymphoma
- malabsorption or malnourishment
- hypercortisolism
- alcoholism or drug abuse
- anemia (hematocrit < 36 in females and <40 in males)
- eating disorder
- dietary restrictions
- Acetaminophen allergy
- Chronic acetaminophen use
- Glucocorticoid therapy
Sites / Locations
- Beth Israel Deaconess Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
High fat meal
Arm Description
Outcomes
Primary Outcome Measures
Change in insulin requirements
Secondary Outcome Measures
Full Information
NCT ID
NCT01292590
First Posted
October 21, 2010
Last Updated
April 25, 2017
Sponsor
Joslin Diabetes Center
Collaborators
Beth Israel Deaconess Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01292590
Brief Title
Effect of Dietary Fat on Glycemic Control in Type 1 Diabetes
Official Title
Use of Closed Loop Control to Examine the Effect of Changes in Dietary Fat Intake on Insulin Requirements and Glucose Control
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Joslin Diabetes Center
Collaborators
Beth Israel Deaconess Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if dietary fat alters insulin requirements in type 1 diabetes.
Detailed Description
This cross-over prospective study will require a two day admission to the clinical research center. Subjects will undergo closed loop glucose control and will received a diet with controlled macronutrient content.
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
High fat meal
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
High fat meal
Other Intervention Name(s)
Macronutrient
Intervention Description
40 grams saturated fat
Primary Outcome Measure Information:
Title
Change in insulin requirements
Time Frame
postprandially until 8 hours
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:
type 1 diabetes using insulin pump and CGM
Exclusion Criteria:
renal or hepatic failure
cancer or lymphoma
malabsorption or malnourishment
hypercortisolism
alcoholism or drug abuse
anemia (hematocrit < 36 in females and <40 in males)
eating disorder
dietary restrictions
Acetaminophen allergy
Chronic acetaminophen use
Glucocorticoid therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard Wolpert, MD
Organizational Affiliation
Joslin Diabetes Center/Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Dietary Fat on Glycemic Control in Type 1 Diabetes
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