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

Primary Purpose

Pediatric Obesity

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Serum insulin level
Serum Leptin test
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pediatric Obesity focused on measuring Leptin, Insulin, Sweet Responsiveness, Weight Loss

Eligibility Criteria

8 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Weight loss with bariatric surgery

    Weight Loss

    Arm Description

    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

    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

    Outcomes

    Primary Outcome Measures

    Higher insulin and leptin levels will be associated with lower sweet taste sensitivity and perception, and higher body fat percentage and z-BMI
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    August 26, 2019
    Last Updated
    June 22, 2023
    Sponsor
    State University of New York at Buffalo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04600648
    Brief Title
    Sweet Taste Responsiveness in Relation to Insulin, Leptin and Adiposity Among Obese Treatment Seeking Children
    Official Title
    Sweet Taste Responsiveness in Relation to Insulin, Leptin and Adiposity Among Obese Treatment Seeking Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    poor enrollment
    Study Start Date
    September 20, 2018 (Actual)
    Primary Completion Date
    August 2, 2019 (Actual)
    Study Completion Date
    August 2, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    State University of New York at Buffalo

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pediatric Obesity
    Keywords
    Leptin, Insulin, Sweet Responsiveness, Weight Loss

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Weight loss with bariatric surgery
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    Weight Loss
    Arm Type
    Active Comparator
    Arm Description
    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 Type
    Diagnostic Test
    Intervention Name(s)
    Serum insulin level
    Intervention Description
    Measure levels before and after weight loss related to bariatric surgery
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Serum Leptin test
    Intervention Description
    Measure levels before and after weight loss related to lifestyle change weight loss
    Primary Outcome Measure Information:
    Title
    Higher insulin and leptin levels will be associated with lower sweet taste sensitivity and perception, and higher body fat percentage and z-BMI
    Description
    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
    Time Frame
    to be measured at 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

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