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Effect of Dietary Fat on Glycemic Control in Type 1 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01292590
First Posted: February 9, 2011
Last Update Posted: April 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Joslin Diabetes Center
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT01292590     History of Changes
Other Study ID Numbers: 2010-P-000140/1; BIDMC
First Submitted: October 21, 2010
First Posted: February 9, 2011
Last Update Posted: April 26, 2017
Last Verified: April 2017

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