Effect of Dietary Fat on Glycemic Control in Type 1 Diabetes

Use of Closed Loop Control to Examine the Effect of Changes in Dietary Fat Intake on Insulin Requirements and Glucose Control

Sponsors

Lead Sponsor: Joslin Diabetes Center

Collaborator: Beth Israel Deaconess Medical Center

Source Joslin Diabetes Center
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.

Overall Status Completed
Start Date September 2010
Completion Date September 2011
Primary Completion Date September 2011
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in insulin requirements postprandially until 8 hours
Enrollment 10
Condition
Intervention

Intervention Type: Other

Intervention Name: High fat meal

Description: 40 grams saturated fat

Arm Group Label: High fat meal

Other Name: Macronutrient

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Howard Wolpert, MD Principal Investigator Joslin Diabetes Center/Beth Israel Deaconess Medical Center
Location
Facility: Beth Israel Deaconess Medical Center
Location Countries

United States

Verification Date

April 2017

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: High fat meal

Type: Experimental

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov