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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Recruitment Status : Withdrawn (poor enrollment)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

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

Condition or disease Intervention/treatment Phase
Pediatric Obesity Diagnostic Test: Serum insulin level Diagnostic Test: Serum Leptin test Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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
Official Title: Sweet Taste Responsiveness in Relation to Insulin, Leptin and Adiposity Among Obese Treatment Seeking Children
Actual Study Start Date : September 20, 2018
Actual Primary Completion Date : August 2, 2019
Actual Study Completion Date : August 2, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Diagnostic Test: Serum insulin level
Measure levels before and after weight loss related to bariatric surgery

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
Diagnostic Test: Serum Leptin test
Measure levels before and after weight loss related to lifestyle change weight loss




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 14 Years   (Child)
Accepts Healthy Volunteers:   No
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.
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Responsible Party: Carroll M. Harmon, MD PhD, MD, Surgeon-in-Chief and Program Director, University at Buffalo
ClinicalTrials.gov Identifier: NCT04600648    
Other Study ID Numbers: 00002306
First Posted: October 23, 2020    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carroll M. Harmon, MD PhD, University at Buffalo:
Leptin
Insulin
Sweet Responsiveness
Weight Loss
Additional relevant MeSH terms:
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Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs