Eating Disorders in Type 1 Diabetes: Mechanisms of Comorbidity
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Purpose
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.
| Condition |
|---|
|
Type 1 Diabetes Eating Disorder |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Cross-Sectional |
| Official Title: | Eating Disorders in Type 1 Diabetes: Mechanisms of Comorbidity |
- Blood Glucose Values [ Time Frame: 72 Hours ] [ Designated as safety issue: No ]
- Ecological Momentary Assessment of Emotional and Behavioral Outcomes [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | December 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
UNC and Duke Endocrine Clinics Community of the Durham, Chapel Hill and Raleigh area
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
Contacts and Locations| Contact: Rhonda M Merwin, PhD | 919-681-7231 | Rhonda.Merwin@duke.edu |
| United States, North Carolina | |
| Duke University Health System | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Lisa K Honeycutt, MA, LPC 919-684-0149 lisa.honeycutt@duke.edu | |
| Principal Investigator: Rhonda M Merwin, PhD | |
| Principal Investigator: | Rhonda Merwin, PhD | Site Principal Investigator |
More Information
No publications provided
| Responsible Party: | Duke University |
| ClinicalTrials.gov Identifier: | NCT01513746 History of Changes |
| Other Study ID Numbers: | Pro00031840 |
| Study First Received: | January 17, 2012 |
| Last Updated: | March 4, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Duke University:
|
Type 1 Diabetes Type 1 Diabetes Mellitus Eating Disorders Insulin Omission |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Eating Disorders Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases Mental Disorders |
ClinicalTrials.gov processed this record on May 21, 2013