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Completed

NCT Number: NCT01292590

Effect of Dietary Fat on Glycemic Control in Type 1 Diabetes

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

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

high fat meal

Other

40 grams saturated fat

Other names: Macronutrient

Primary outcomes

  1. Change in insulin requirements

    Time frame: postprandially until 8 hours

Sponsors and collaborators

Lead sponsor

Joslin Diabetes Center

Other

Collaborators

  • Beth Israel Deaconess Medical Center

Registry information

Official study title

Use of Closed Loop Control to Examine the Effect of Changes in Dietary Fat Intake on Insulin Requirements and Glucose Control

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 9, 2011
Registry last updated
Apr 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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