Eating Disorders in Type 1 Diabetes: Mechanisms of Comorbidity

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01513746

Enrollment

Registered

2012-01-20

Start date

2011-12-31

Completion date

2014-08-31

Last updated

2014-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eating Disorder, Type 1 Diabetes

Keywords

Type 1 Diabetes, Type 1 Diabetes Mellitus, Eating Disorders, Insulin Omission

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Blood Glucose Values	72 Hours

Secondary

Measure	Time frame
Ecological Momentary Assessment of Emotional and Behavioral Outcomes	72 hours

Countries

United States

Outcome results