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

NCT ID: NCT04600648

Last Updated: 2023-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-20

Study Completion Date

2019-08-02

Brief Summary

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This study will explore whether a relationship exists between insulin and leptin resistance, sweet taste responsiveness, and adiposity.

Detailed Description

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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.

Conditions

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Pediatric Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Compare the level of insulin, leptin, and sweet taste sensitivity and perception before and after short term weight loss and bariatric surgery
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Serum insulin level

Intervention Type DIAGNOSTIC_TEST

Measure levels before and after weight loss related to bariatric surgery

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

Group Type ACTIVE_COMPARATOR

Serum Leptin test

Intervention Type DIAGNOSTIC_TEST

Measure levels before and after weight loss related to lifestyle change weight loss

Interventions

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Serum insulin level

Measure levels before and after weight loss related to bariatric surgery

Intervention Type DIAGNOSTIC_TEST

Serum Leptin test

Measure levels before and after weight loss related to lifestyle change weight loss

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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State University of New York at Buffalo

OTHER

Sponsor Role lead

Responsible Party

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Carroll M. Harmon, MD PhD

MD, Surgeon-in-Chief and Program Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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00002306

Identifier Type: -

Identifier Source: org_study_id

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