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Type 1 Diabetes and Eating Disorder Diurnal Glucose Patterns (REACT5)

This study is not yet open for participant recruitment.
Verified April 2013 by Park Nicollet Institute
Sponsor:
Collaborators:
Park Nicollet Foundation
Melrose Institute
International Diabetes Center at Park Nicollet
Information provided by (Responsible Party):
Park Nicollet Institute
ClinicalTrials.gov Identifier:
NCT01390636
First received: June 29, 2011
Last updated: April 12, 2013
Last verified: April 2013
History of Changes
  Purpose

The purpose of this study is to use data from the Continuous Glucose Monitor (CGM) to determine the degree of variation in glucose levels of individuals with an eating disorder and type 1 diabetes and only an eating disorder.


Condition
Type I Diabetes Mellitus Without Complication
Eating Disorder

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Characterizing Diurnal Glucose Patterns of Individuals With Type 1 Diabetes and Eating Disorders

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by Park Nicollet Institute:

Primary Outcome Measures:
  • Variation in Glycemic Profiles of ED-DMT1 and ED/only [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Determine the degree of variation in glycemic profiles of individuals with ED-DMT1 and ED/only using Continuous Glucose Monitoring (CGM). CGM will be graphically and statistically represented by an Ambulatory Glucose Profile (AGP).


Secondary Outcome Measures:
  • Impact of Dietary Intake on Glucose Profiles of ED-DMT1 and ED/only [ Time Frame: 10 days ] [ Designated as safety issue: No ]
    Determine the impact of dietary intake and planned physical activity on glucose profiles of individuals with ED-DMT1 and ED/only using Continuous Glucose Monitoring (CGM). CGM will be graphically and statistically represented by an Ambulatory Glucose Profile (AGP).


Estimated Enrollment: 45
Study Start Date: June 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
ED-DMT1 and ED/only
Eating Disorder and Type 1 Diabetes and only an Eating Disorder

Detailed Description:

The specific aims of the proposed research are to:

2.1 Determine the degree of variation in glycemic profiles of individuals with an Eating Disorder and Type 1 Diabetes (ED-DMT1) and an Eating Disorder only (ED/only); and

2.2 Determine the impact of nutritional intake and planned physical activity on glucose profiles of individuals with ED-DMT1 and ED/only.

These aims will be examined by characterizing:

  • glucose exposure, as measured by area under the Ambulatory Glucose Profile (AGP) median curve;
  • glucose variability, as measured by the AGP inter-quartile range; and
  • glucose stability, as measured by change in the AGP median curve.
  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Current Melrose Institute Patient

Criteria

Inclusion Criteria:

  • Admitted to the ISL unit at Melrose Institute

  • Diagnosed with an eating disorder (Anorexia Nervosa, Bulimia Nervosa or Eating Disorder Not Otherwise Specified)

    1. For ED-DMT1 group: Diagnosis of an eating disorder AND diagnosis of type 1 diabetes.
    2. For ED/only group: Diagnosis of an eating disorder AND no history/diagnosis of type 1 or type 2 diabetes.
  • Female.
  • At least 14 years of age.

  • Able to provide informed consent.

    1. If the potential participant's age is at least 18 years she must be able to provide informed consent.
    2. If the potential participant is less than 18 years she must have a parent or guardian able and willing to provide written informed consent on the participant's behalf. In addition, the participant must be willing to sign a consent on her own behalf.
  • Participants must be able and willing to utilize the CGM system and perform required calibrations using self-monitored blood glucose.

Exclusion Criteria:

  • Male.
  • Age < 14 years.
  • History of self-injurious behavior that the senior clinician feels precludes participation.
  • Unable to understand the study protocol.
  • Unwilling to follow the study protocol.
  • Participation in any competing research study.
  • Planned ISL admission for <4 days.
  • Pregnant.
  • Not able to communicate in English.
  • Regular use of acetaminophen or acetaminophen containing medications and not able to modify their medication to a non-acetaminophen based medication.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01390636

Contacts
Contact: Deborah Mangham, MD 952-993-5990 deborah.mangham@parknicollet.com
Contact: Jane A Norstrom, MA 952-993-3934 jane.norstrom@parknicollet.com

Locations
United States, Minnesota
Melrose Institute Not yet recruiting
Minneapolis, Minnesota, United States, 55416
Principal Investigator: Mazze S Mazze, PhD            
Sub-Investigator: Richard M Bergenstal, MD            
Sub-Investigator: Joel Jahraus, MD            
Sub-Investigator: Deborah Mangham, MD            
Sub-Investigator: Jane A Norstrom, MA            
Sub-Investigator: David Parker, MD, MPH            
Sub-Investigator: Sara Richter, MS            
Sub-Investigator: Ellie S Strock, APRN-BC            
Sponsors and Collaborators
Park Nicollet Institute
Park Nicollet Foundation
Melrose Institute
International Diabetes Center at Park Nicollet
Investigators
Principal Investigator: Mazze S Mazze, PhD International Diabetes Center at Park Nicollet
  More Information

No publications provided

Responsible Party: Park Nicollet Institute
ClinicalTrials.gov Identifier: NCT01390636     History of Changes
Other Study ID Numbers: 04126-11-C
Study First Received: June 29, 2011
Last Updated: April 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Park Nicollet Institute:
Continuous Glucose Monitoring
Type 1 Diabetes and an Eating Disorder
Eating Disorder Only

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 22, 2013