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Eating Disorders in Type 1 Diabetes: Mechanisms of Comorbidity

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01513746
First Posted: January 20, 2012
Last Update Posted: August 26, 2014
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:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Duke University
  Purpose
The purpose of the study is to investigate how people with type 1 diabetes experience and manage their diabetes, eating, and weight. Summary of the Study: If you choose to participate, you will complete a set of questionnaires and a structured interview. You will then wear a continuous glucose monitor and use your cell phone to answer study questions for a period of 3 days. The questions come in the form of regular phone calls between the hours of 8:00 a.m. and 10:00 p.m. Each call takes only a minute or two to complete. You will also be asked to call in and answer study questions at other times during the day, especially after eating. The study involves a minimum of 2 clinic visits to Duke. Participants who live greater than 1.5 hours from Duke can be approved to take part in the study by phone/Skype. Participants will receive and return study materials through the mail.

Condition
Type 1 Diabetes Eating Disorder

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Eating Disorders in Type 1 Diabetes: Mechanisms of Comorbidity

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Blood Glucose Values [ Time Frame: 72 Hours ]

Secondary Outcome Measures:
  • Ecological Momentary Assessment of Emotional and Behavioral Outcomes [ Time Frame: 72 hours ]

Enrollment: 83
Study Start Date: December 2011
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Detailed Description:
Eating disorders (ED) are far more prevalent among individuals with type 1 diabetes (T1D) than the general population. Yet what accounts for the increased prevalence of ED in T1D, and how to effectively treat these patients is unknown. ED in T1D is dangerous. T1D patients with ED not only engage in behaviors common among non-diabetic ED patients (like binge eating), but also might omit insulin to prevent weight gain. The goal of this study is to understand the psychophysiological precipitants to ED behavior among T1D patients.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
UNC and Duke Endocrine Clinics Community of the Durham, Chapel Hill and Raleigh area
Criteria

Inclusion Criteria:

  1. Adult (aged 18-65)
  2. Diagnosed with type 1 diabetes
  3. Clinically significant eating disorder symptoms
  4. Currently monitored by a physician

Exclusion:

  1. Severe hypoglycemic unawareness
  2. Pregnancy
  3. Current or history of psychosis or mania
  4. Current substance abuse
  5. Non-English speaking
  6. Significant deficits in intellectual functioning
  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): NCT01513746


Locations
United States, North Carolina
Duke University Health System
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Rhonda Merwin, PhD Site Principal Investigator
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01513746     History of Changes
Other Study ID Numbers: Pro00031840
First Submitted: January 17, 2012
First Posted: January 20, 2012
Last Update Posted: August 26, 2014
Last Verified: August 2014

Keywords provided by Duke University:
Type 1 Diabetes
Type 1 Diabetes Mellitus
Eating Disorders
Insulin Omission

Additional relevant MeSH terms:
Disease
Diabetes Mellitus
Diabetes Mellitus, Type 1
Feeding and Eating Disorders
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Mental Disorders