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. 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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Eating Disorder Endocrine System Diseases Feeding and Eating Disorders Glucose Metabolism Disorders Immune System Diseases Mental Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Health System

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult (aged 18-65)
Diagnosed with type 1 diabetes
Clinically significant eating disorder symptoms
Currently monitored by a physician

Exclusion:

Severe hypoglycemic unawareness
Pregnancy
Current or history of psychosis or mania
Current substance abuse
Non-English speaking
Significant deficits in intellectual functioning

Treatment and study plan

Primary outcomes

Blood Glucose Values

Time frame: 72 Hours

Secondary outcomes

Ecological Momentary Assessment of Emotional and Behavioral Outcomes

Time frame: 72 hours

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

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

Registry information

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Jan 20, 2012
Registry last updated: Aug 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed