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Thyroid Hormone-Induced Lipolysis: An In Vivo Microdialysis Study
This study is currently recruiting participants.
Summary | Eligibility | Citations | Contacts
Summary
Number |
06-DK-0133 |
Sponsoring Institute |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
Recruitment Detail |
Type: Participants currently recruited/enrolled |
Referral Letter Required |
No |
Population Exclusion(s) |
Children |
Special Instructions |
Currently Not Provided |
Keywords |
Deiodinase; |
Recruitment Keyword(s) |
Healthy Volunteer; |
Condition(s) |
Healthy Volunteers |
Investigational Drug(s) |
None |
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
|
Microperfusion is based on the exchange of substances across tiny holes of a small plastic tube called a "probe," which is inserted after numbing the skin over a fat pad. Through these openings, the fat pad is continuously rinsed with small amounts of fluid, and an exchange of substances occurs. The fluid drips from the other opening of the probe and is collected in a vial. Small amounts of study drugs are infused and the amount of substances released by the fat pad in response to them are measured.
Healthy normal volunteers 18 years of age and older may be eligible for this study. Candidates are screened with a medical history, physical examination and blood tests.
Participants undergo microperfusion. A needle is placed in an arm vein for collecting blood samples before and at the end of the experiment for measuring thyroid hormones and other substances in the blood. The skin over the fat pad next to the umbilicus (navel) is numbed and two microperfusion probes are inserted. A salt water solution is infused into the fat pad for one hour and the substances in the fluid are measured as the fluid leaves the fat pad. After 1 hour isoproterenol, a drug that aids in energy production by fat, is added to help determine the level of fat metabolism. After an additional hour small amounts of thyroid hormone are added to the fluid and samples are collected as they leave the body. Two catheters are inserted during each experiment. Small volumes of sterile fluid are circulated continuously in the tubing and samples are collected at regular intervals.
Eligibility
INCLUSION CRITERIA:
- Age greater than or equal to 18 years, male or female.
- Written informed consent.
EXCLUSION CRITERIA:
- Hypo- or hyper-thyroid (history or TSH greater than 5.0 and less than 0.4 miU/L)
- Blood pressure greater than 140/90 mmHg [17] or current antihypertensive therapy
- History of cardiovascular disease
- BMI less than or equal to 20 or greater than or equal to 30 Kg/m(2).
- Diabetes mellitus (serum glucose greater than or equal to 126 mg/dL).
- Hypercholesterolemia (serum levels greater than or equal to 240 mg/dL), hypertriglyceridemia (plasma levels greater than or equal to 220 mg/dL) and/or use of antilipemic therapy.
- Liver disease or ALT serum level greater than two fold the upper laboratory reference limit.
- Renal insufficiency or estimated creatinine clearance less than or equal to 50 mL/min (Cockcroft method).
- History of illicit drug or alcohol abuse within the last 5 years; current use of drugs (by history) or alcohol (CAGE greater than 3).
- Psychiatric conditions or behavior that would be incompatible with safe and successful participation in this study
- Current use of medications/dietary supplements/alternative therapies known to alter thyroid function.
- Allergy to ethanol, levothyroxine, liothyronine, isoproterenol, lidocaine.
- Pregnancy/breastfeeding.
- Current smoker
All subjects will be fully informed of the aim, nature, and risks of the study prior to giving written informed consent.
Citations:
Contacts:
Principal Investigator |
Referral Contact |
For more information http://clinicalstudies.info.nih.gov. |
| Francesco S. Celi, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Institutes of Health Building 10 Room 6-3940 10 Center Drive Bethesda, Maryland 20892 (301) 496-8711 cizzag@mail.nih.gov |
Joyce D. Linderman, R.N. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Institutes of Health Building 10 Room 5-5750 10 Center Drive Bethesda, Maryland 20892 (301) 402-6371 megan.mattingly@nih.gov |
Patient Recruitment and Public Liaison Office Building 61 10 Cloister Court Bethesda, Maryland 20892-4754 Toll Free: 1-800-411-1222 TTY: 301-594-9774 (local),1-866-411-1010 (toll free) Fax: 301-480-9793 prpl@mail.cc.nih.gov |
Clinical Trials Number:
NCT00312715
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