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

NCT04600648 | Withdrawn

• 1 other identifier: 00002306
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Pediatric Obesity

Keywords

Leptin; Insulin; Sweet Responsiveness; Weight Loss

Outcome Measures

Primary Outcomes (1)

• 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

  to be measured at 6 months

Study Arms (2)

Weight loss with bariatric surgery

ACTIVE COMPARATOR

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

Diagnostic Test: Serum insulin level

Weight Loss

ACTIVE COMPARATOR

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

Diagnostic Test: Serum Leptin test

Interventions

Serum insulin level DIAGNOSTIC_TEST

Measure levels before and after weight loss related to bariatric surgery

Weight loss with bariatric surgery

Serum Leptin test DIAGNOSTIC_TEST

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

Weight Loss

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• State University of New York at Buffalo: lead

MeSH Terms

Conditions

Pediatric Obesity; Insulin Resistance; Weight Loss

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Body Weight Changes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Surgeon-in-Chief and Program Director

Model Details: Compare the level of insulin, leptin, and sweet taste sensitivity and perception before and after short term weight loss and bariatric surgery

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: October 23, 2020
• Study Start: September 20, 2018
• Primary Completion: August 2, 2019
• Study Completion: August 2, 2019
• Last Updated: June 26, 2023

Record last verified: 2020-10