Eating Disorders in Type 1 Diabetes: Mechanisms of Comorbidity

NCT ID: NCT01513746

Last Updated: 2014-08-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 83 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2014-08-31

Brief Summary

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.

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.

Conditions

Type 1 Diabetes; Eating Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rhonda Merwin, PhD

Role: PRINCIPAL_INVESTIGATOR

Site Principal Investigator

Locations

Duke University Health System

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00031840

Identifier Type: -

Identifier Source: org_study_id