Effect of Dietary Fat on Glycemic Control in Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01292590
• Other study ID #: 2010-P-000140/1; BIDMC
• Status: Completed
• Phase: N/A
• First received: October 21, 2010
• Last updated: April 25, 2017
• Start date: September 2010
• Est. completion date: September 2011

Study information

• Verified date: April 2017
• Source: Joslin Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if dietary fat alters insulin requirements in type 1 diabetes.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Other:
• High fat meal
40 grams saturated fat

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Joslin Diabetes Center	Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in insulin requirements		postprandially until 8 hours