Eating Disorders in Type 1 Diabetes: Mechanisms of Comorbidity

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01513746
First received: January 17, 2012
Last updated: August 25, 2014
Last verified: August 2014
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ecological Momentary Assessment of Emotional and Behavioral Outcomes [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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: NCT01513746

Locations
United States, North Carolina
Duke University Health System
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Rhonda Merwin, PhD Site Principal Investigator
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01513746     History of Changes
Other Study ID Numbers: Pro00031840
Study First Received: January 17, 2012
Last Updated: August 25, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 23, 2014