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Effect of Dietary Fat on Glycemic Control in Type 1 Diabetes

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.
ClinicalTrials.gov Identifier: NCT01292590
Recruitment Status : Completed
First Posted : February 9, 2011
Last Update Posted : April 26, 2017
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Joslin Diabetes Center

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

Condition or disease Intervention/treatment
Type 1 Diabetes Other: High fat meal

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
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
Study Start Date : September 2010
Primary Completion Date : September 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: High fat meal Other: High fat meal
40 grams saturated fat
Other Name: Macronutrient

Primary Outcome Measures :
  1. Change in insulin requirements [ Time Frame: postprandially until 8 hours ]

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

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

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

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

Responsible Party: Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT01292590     History of Changes
Other Study ID Numbers: 2010-P-000140/1; BIDMC
First Posted: February 9, 2011    Key Record Dates
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