Eating Disorders in Type 1 Diabetes: Mechanisms of Comorbidity

Type 1 Diabetes Clinical Trial

Official title:

Eating Disorders in Type 1 Diabetes: Mechanisms of Comorbidity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01513746
• Other study ID #: Pro00031840
• Status: Completed
• Phase: N/A
• First received: January 17, 2012
• Last updated: August 25, 2014
• Start date: December 2011
• Est. completion date: August 2014

Study information

• Verified date: August 2014
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Eating Disorder
• Eating Disorders
• Type 1 Diabetes

Locations

Country	Name	City	State
United States	Duke University Health System	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Glucose Values		72 Hours	No
Secondary	Ecological Momentary Assessment of Emotional and Behavioral Outcomes		72 hours	No