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Brain Regulation of Appetite in Twins (BRAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02483663
Recruitment Status : Completed
First Posted : June 29, 2015
Last Update Posted : October 27, 2017
Sponsor:
Collaborators:
Fred Hutchinson Cancer Center
Columbia University
Information provided by (Responsible Party):
Ellen Schur, MD, MS, University of Washington

Study Description
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Brief Summary:
Scientists are examining the genetic and environmental influences on appetite and weight gain. The main purpose of this study is to look at how genetic and environmental factors may influence how the brain regulates appetite and food intake. Understanding how the brain regulates appetite and food intake may eventually lead to new ways to help people avoid obesity or lose weight.

Condition or disease Intervention/treatment
Obesity Appetite Device: Functional Magnetic Resonance Imaging Radiation: Dual Energy X-ray absorptiometry Other: Questionnaires Other: Mood and Appetite Ratings Other: Test Meals Other: Computer Tests Procedure: Intravenous Catheter (IV) placement

Study Design
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Study Type : Observational
Actual Enrollment : 122 participants
Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Brain Regulation of Appetite in Twins
Study Start Date : August 2010
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015
Groups and Cohorts
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Group/Cohort Intervention/treatment
27 Monozygotic Pairs Device: Functional Magnetic Resonance Imaging
Measure brain activity.
Other Name: fMRI

Radiation: Dual Energy X-ray absorptiometry
Body composition measurements.
Other Name: DXA

Other: Questionnaires
Questionnaires related to: health, weight, sleep, mood, dietary habits, attitudes towards eating, how you describe yourself.

Other: Mood and Appetite Ratings
Answer questions about how you are feeling at the moment.

Other: Test Meals
Breakfast, a snack, and lunch provided during study visit.

Other: Computer Tests
Perform a series of computer tests to determine reaction time.

Procedure: Intravenous Catheter (IV) placement
Blood samples collected throughout regular intervals during the study visit day to measure levels of hormones involved in regulating appetite and body weight. We will also determine if twins are fraternal or identical and will examine DNA to see if participants carry two genes that affect appetite or body weight, the FTO gene and the MC4R gene.
27 Dizygotic Pairs Device: Functional Magnetic Resonance Imaging
Measure brain activity.
Other Name: fMRI

Radiation: Dual Energy X-ray absorptiometry
Body composition measurements.
Other Name: DXA

Other: Questionnaires
Questionnaires related to: health, weight, sleep, mood, dietary habits, attitudes towards eating, how you describe yourself.

Other: Mood and Appetite Ratings
Answer questions about how you are feeling at the moment.

Other: Test Meals
Breakfast, a snack, and lunch provided during study visit.

Other: Computer Tests
Perform a series of computer tests to determine reaction time.

Procedure: Intravenous Catheter (IV) placement
Blood samples collected throughout regular intervals during the study visit day to measure levels of hormones involved in regulating appetite and body weight. We will also determine if twins are fraternal or identical and will examine DNA to see if participants carry two genes that affect appetite or body weight, the FTO gene and the MC4R gene.


Outcome Measures
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Primary Outcome Measures :
  1. Meal-induced nutrient and hormonal changes in plasma (insulin, GLP-1, ghrelin, glucose) [ Time Frame: Baseline ]
  2. Brain activation during fMRI in satiety-related regions [ Time Frame: Baseline ]
  3. Body composition: fasting leptin and dual energy X-ray absorptiometry (DXA) [ Time Frame: Baseline ]
  4. DNA evaluation of FTO genotypes [ Time Frame: Baseline ]
  5. Objective satiety: caloric and macronutrient intake [ Time Frame: Baseline ]
  6. Subjective satiety: visual analog scale (VAS) scores and appeal ratings [ Time Frame: Baseline ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Monozygotic and dizygotic twins recruited from the University of Washington Twin Registry
Criteria

Inclusion Criteria:

  • Ability and willingness to come with their twin to the University of Washington (Seattle)
  • Additional Criteria for Aim 1 random sample only: Member of randomly selected MZ pair or
  • Additional criteria for Aim 2 random sample only: One member of MZ or same-sex DZ pair with BMI of at least 30 kg/m^2
  • Additional criteria for Aim 3 sample only: Member of randomly selected MZ pair, and not BMI discordant ≥ 5 kg/m^2

Exclusion Criteria:

  • History of weight loss surgery or active participation in weight loss program
  • Major medical problem (e.g., diabetes, cancer)
  • Current use of weight loss medications or other medications known to alter appetite
  • Pregnancy or menopause
  • MRI contraindication (i.e., implanted metal, claustrophobia)
  • Lifetime eating disorder
  • Current smoking
  • Current heavy alcohol use (≥2 drinks per day for females and ≥ 3 drinks per day for males)
  • Self-reported weight >330 pounds at time of phone screening. MRI cannot accommodate all shapes or weights. Inability to have MRI does not exclude subject from participating in other study procedures.
  • BMI < 18.5 or > 45 kg/m^2
  • Allergies to study foods or inability to taste
  • Twins were raised apart
  • Co-twin not eligible or not willing to participate
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02483663


Locations
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United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Fred Hutchinson Cancer Center
Columbia University
Investigators
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Principal Investigator: Ellen Schur, MD, MS University of Washington
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ellen Schur, MD, MS, Associate Professor, Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT02483663    
Other Study ID Numbers: 38970
First Posted: June 29, 2015    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Keywords provided by Ellen Schur, MD, MS, University of Washington:
Twins
Obesity
Appetite
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight