Macronutrient Regulation of Ghrelin and Peptide YY

NCT02464514 | Completed DMC

• 2 other identifiers: 50281K23RR021979
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The hyperghrelinemia of children with PWS provides a unique model by which to explore the hormonal and metabolic effects of orexigenic hormones in normal and pathologic conditions. An important question to be addressed by this proposed research includes the macro-nutrient regulation of ghrelin and PYY in obese children and children with PWS. As ghrelin antagonists are considered potential future anti-obesity agents, it is essential to gain understanding of the developmental, nutritional and hormonal regulation of this important orexigenic hormone in children.

Conditions

Obesity; Prader Willi Syndrome

Keywords

Obesity; Orexigen; Insulin; Leptin; Adiponectin; Growth hormone replacement

Outcome Measures

Primary Outcomes (2)

• Change in ghrelin levels

  The change in ghrelin levels will be measured before and after meal consumption in children with PWS, and healthy obese controls. Following an overnight 8 hour fast, subjects will be given either a high carbohydrate or high fat meal. Subjects will be allowed 25 minutes to consume everything on their food tray. Blood samples will be obtained before the meal (fasting) and every 30 minutes thereafter for 4 hours.

  4 hours

• Change in PYY concentrations

  The change in PYY concentration levels will be measured before and after meal consumption in children with PWS, and healthy obese controls. Following an overnight 8 hour fast, subjects will be given either a high carbohydrate or high fat meal. Subjects will be allowed 25 minutes to consume everything on their food tray. Blood samples will be obtained before the meal (fasting) and every 30 minutes thereafter for 4 hours.

  4 hours

Secondary Outcomes (4)

• Fasting Insulin-like growth factor 1 (IGF-1) levels

  Baseline

• Neuropeptide Y (NPY)

  Baseline

• Gastric inhibitory polypeptide (GIP)

  Baseline

• Glucagon-like peptide-1 (GLP-1)

  Baseline

Study Arms (2)

Healthy obese children

OTHER

High carbohydrate meal High fat meal

Other: High carbohydrate meal; Other: High fat meal

Children with Prader Willi Syndrome

OTHER

High carbohydrate meal High fat meal

Other: High carbohydrate meal; Other: High fat meal

Interventions

High carbohydrate meal OTHER

65% carbohydrate, 17% protein, and 18% fat

Children with Prader Willi Syndrome; Healthy obese children

High fat meal OTHER

58% fat, 17% protein, and 25% carbohydrate

Children with Prader Willi Syndrome; Healthy obese children

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of PWS confirmed by chromosome analysis (i.e. interstitial deletion of paternally-derived chromosome 15Q, uniparental maternal disomy or other chromosome 15 abnormalities) or normal control
• Subjects with simple obesity
• Ages 5 years to 17 years
• Written informed consent and assent obtained and willingness to comply with the study schedule and procedures.
• Free T4, TSH values in the normal range (either endogenous or with thyroxine replacement)

You may not qualify if:

• Patients with any other clinically significant disease that would have an impact on body composition including diabetes mellitus, chronic inflammatory bowel disease, chronic severe liver or kidney disease or neurologic disorders
• Concomitant use of an investigational drug in the past year
• Patients with an active malignancy
• Parent or legal guardian unable to provide informed consent.

Sponsors & Collaborators

• Duke University: lead
• National Institutes of Health (NIH): collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• Foundation for Prader-Willi Research: collaborator
• Stollery Children's Hospital Foundation: collaborator
• Alberta Diabetes Institute: collaborator
• Sarah W. Stedman Nutrition and Metabolism Center: collaborator
• American Diabetes Association: collaborator
• Duke Children's Miracle Network: collaborator
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

• Gumus Balikcioglu P, Balikcioglu M, Muehlbauer MJ, Purnell JQ, Broadhurst D, Freemark M, Haqq AM. Macronutrient Regulation of Ghrelin and Peptide YY in Pediatric Obesity and Prader-Willi Syndrome. J Clin Endocrinol Metab. 2015 Oct;100(10):3822-31. doi: 10.1210/jc.2015-2503. Epub 2015 Aug 10.

  PMID: 26259133 DERIVED

MeSH Terms

Conditions

Obesity; Prader-Willi Syndrome; Insulin Resistance

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Imprinting Disorders; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Andrea Haqq, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Michael Freemark, MD

  Duke University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2015
• First Posted: June 8, 2015
• Study Start: January 1, 2004
• Primary Completion: December 1, 2005
• Study Completion: December 1, 2005
• Last Updated: August 10, 2015

Record last verified: 2015-06

Locations

US (1)