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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
History of Changes
  Purpose

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


Condition Intervention
Type 1 Diabetes
 Other: High fat meal

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of Closed Loop Control to Examine the Effect of Changes in Dietary Fat Intake on Insulin Requirements and Glucose Control

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Joslin Diabetes Center:

Primary Outcome Measures:
  • Change in insulin requirements [ Time Frame: postprandially until 8 hours ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: September 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High fat meal Other: High fat meal
40 grams saturated fat
Other Name: Macronutrient

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01292590

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Joslin Diabetes Center
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Howard Wolpert, MD Joslin Diabetes Center/Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: Howard Wolpert, Senior Physician & Director of Diabetes Technology Programs, Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT01292590     History of Changes
Other Study ID Numbers: 2010-P-000140/1; BIDMC
Study First Received: October 21, 2010
Last Updated: September 18, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013