A Study of Effect of Different Biochemical Markers including Leptin and Spexin in Children Before and After Having Hypothalamus Surgery
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-005774
Sponsor Protocol Number: 16-005774
About this study
The purpose of this study is to learn more about the changes in levels of Spexin, leptin and other biomarkers such as adiponectin and resting energy expenditure before and after hypothalamic surgery.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
Children with Hypothalamic Ovesity:
- History of a tumor in the sellar/suprasellar region with hypothalamic involvement
- Age 2-17 years
- Stable hormone replacement therapy for more than 6 months (with levothyroxine, glucocorticoids and sex steroids)
Control Samples:
- Patients with simple obesity who have previously participated in a clinical trial aimed at studying the effect of vitamin-D supplementation on insulin action
- Age 12-18 years
Exclusion Criteria:
- Untreated pituitary dysfunction except for untreated growth hormone deficiency
- Type 1 or 2 diabetes mellitus
- Previous (within 6-months) or current use of weight loss medication
- Previous (within 6-months) or current use of drugs associated with weight gain (e.g. steroids/anti-psychotics)
- Previous bariatric surgery
- Recent initiation (within 3-months) of anti-hypertensive or lipid medication
- Obesity associated with genetic disorder (monogenetic obesity)
Control Samples:
- Hepatic or Renal disorders.
- Type 1 or Type 2 diabetes mellitus.
- Ongoing use of insulin, metformin, or oral hypoglycemic medications.
- Malabsorption disorders (celiac disease, cystic fibrosis, and inflammatory bowel disease.
- Serum 25(OH) D > 100 ng/mL, and serum calcium > 10.8 mg/dL.
- Use of glucocorticoids or anti-seizure medications in the preceding 6 months, ongoing multivitamin supplementation
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available