Effect of Dietary Fat on Glycemic Control in Type 1 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Howard Wolpert, Joslin Diabetes Center
ClinicalTrials.gov Identifier:
NCT01292590
First received: October 21, 2010
Last updated: September 18, 2012
Last verified: September 2012

October 21, 2010
September 18, 2012
September 2010
September 2011   (final data collection date for primary outcome measure)
Change in insulin requirements [ Time Frame: postprandially until 8 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01292590 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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

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.

Interventional
Not Provided
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 1 Diabetes
Other: High fat meal
40 grams saturated fat
Other Name: Macronutrient
Experimental: High fat meal
Intervention: Other: High fat meal
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01292590
2010-P-000140/1; BIDMC
No
Howard Wolpert, Joslin Diabetes Center
Joslin Diabetes Center
Beth Israel Deaconess Medical Center
Principal Investigator: Howard Wolpert, MD Joslin Diabetes Center/Beth Israel Deaconess Medical Center
Joslin Diabetes Center
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP