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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 13, 2014