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Sweet Taste Responsiveness in Relation to Insulin, Leptin and Adiposity Among Obese Treatment Seeking Children

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ClinicalTrials.gov Identifier: NCT04600648
Recruitment Status : Withdrawn (poor enrollment)
First Posted : October 23, 2020
Last Update Posted : October 23, 2020
Sponsor:
Information provided by (Responsible Party):
Carroll M. Harmon, MD PhD, University at Buffalo

Tracking Information
First Submitted Date  ICMJE August 26, 2019
First Posted Date  ICMJE October 23, 2020
Last Update Posted Date October 23, 2020
Actual Study Start Date  ICMJE September 20, 2018
Actual Primary Completion Date August 2, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2020)
Higher insulin and leptin levels will be associated with lower sweet taste sensitivity and perception, and higher body fat percentage and z-BMI [ Time Frame: to be measured at 6 months ]
insulin and leptin levels will be measured at various time points in an attempt to identify if there is a change is taste senses associated with specific variables be associated with lower sweet taste
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sweet Taste Responsiveness in Relation to Insulin, Leptin and Adiposity Among Obese Treatment Seeking Children
Official Title  ICMJE Sweet Taste Responsiveness in Relation to Insulin, Leptin and Adiposity Among Obese Treatment Seeking Children
Brief Summary This study will explore whether a relationship exists between insulin and leptin resistance, sweet taste responsiveness, and adiposity.
Detailed Description Compared to healthy weight peers, some reports have shown that they are less sensitive to, or perceptive of, sucrose solutions and sweet foods, whereas others have observed the opposite pattern of findings or no difference at all. Among those seeking weight loss treatment, one investigation found perception and preferences for sweet taste remained unchanged after weight loss, and another observed a decreased ability to distinguish sweet taste from other taste solutions. Given these discrepancies in the literature, the proposed study will explore whether a relationship exists between insulin and leptin resistance, sweet taste responsiveness, and adiposity.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Compare the level of insulin, leptin, and sweet taste sensitivity and perception before and after short term weight loss and bariatric surgery
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Pediatric Obesity
Intervention  ICMJE
  • Diagnostic Test: Serum insulin level
    Measure levels before and after weight loss related to bariatric surgery
  • Diagnostic Test: Serum Leptin test
    Measure levels before and after weight loss related to lifestyle change weight loss
Study Arms  ICMJE
  • Active Comparator: Weight loss with bariatric surgery
    Patients scheduled to undergo bariatric surgery will be tested pre and post bariatric surgery. Interventions to be measured are serum Insulin and leptin levels, sweet taste responsiveness, body fat percentage, and z-BMI
    Intervention: Diagnostic Test: Serum insulin level
  • Active Comparator: Weight Loss
    Patients to receive lifestyle weight loss treatment will be tested pre and post bariatric surgery. Interventions to be measured are serum Insulin and leptin levels, sweet taste responsiveness, body fat percentage, and z-BMI
    Intervention: Diagnostic Test: Serum Leptin test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: October 19, 2020)
0
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2, 2019
Actual Primary Completion Date August 2, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient of Children's Healthy Weigh of Buffalo
  • ages of 8-14

If enrolled in the bariatric arm:

• must be scheduled for bariatric surgery prior to enrollment

Exclusion Criteria:

  • Patients unable to get labs drawn at a Kaleida facility
  • Severe hay fever or seasonal allergies within 2 weeks of enrollment
  • smoker or are exposed to second-hand smoke at home,
  • has been dieting to lose weight within the past 6 months of enrollment
  • currently taking any prescription medications that can influence taste or small functions or are pregnant.
  • pregnancy
  • Bariatric arm patients will be excluded if they fail to have the surgery.
Sex/Gender  ICMJE Not Provided
Ages  ICMJE 8 Years to 14 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04600648
Other Study ID Numbers  ICMJE 00002306
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Carroll M. Harmon, MD PhD, University at Buffalo
Study Sponsor  ICMJE State University of New York at Buffalo
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account State University of New York at Buffalo
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP