Eating Disorders in Type 1 Diabetes: Mechanisms of Comorbidity

This study is currently recruiting participants.
Verified March 2013 by Duke University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01513746
First received: January 17, 2012
Last updated: March 4, 2013
Last verified: March 2013

January 17, 2012
March 4, 2013
December 2011
September 2014   (final data collection date for primary outcome measure)
Blood Glucose Values [ Time Frame: 72 Hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01513746 on ClinicalTrials.gov Archive Site
Ecological Momentary Assessment of Emotional and Behavioral Outcomes [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Eating Disorders in Type 1 Diabetes: Mechanisms of Comorbidity
Eating Disorders in Type 1 Diabetes: Mechanisms of Comorbidity

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

UNC and Duke Endocrine Clinics Community of the Durham, Chapel Hill and Raleigh area

  • Type 1 Diabetes
  • Eating Disorder
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
December 2014
September 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact: Rhonda M Merwin, PhD 919-681-7231 Rhonda.Merwin@duke.edu
United States
 
NCT01513746
Pro00031840
Yes
Duke University
Duke University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Rhonda Merwin, PhD Site Principal Investigator
Duke University
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP