"Pecos" B-Adrenergic and PPAR-G Stimulation Upregulates Lipid Metabolism in Human Subcutaneous Fat
This study has been completed.
Sponsor:
Pennington Biomedical Research Center
Information provided by:
Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT00377975
First received: September 17, 2006
Last updated: NA
Last verified: September 2006
History: No changes posted
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Purpose
This study compares four treatments to see which one causes the most weight loss, fat loss, loss of abdominal fat and improvement in blood tests like cholesterol. The four treatments are: Placebo, Ephedrine plus caffeine, Pioglitazone, Combined pioglitazone and ephedrine plus caffeine
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity |
Drug: Ephedrine Drug: Pioglitazone Drug: Caffeine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Synergistic Induction of UCP-1 by Ephedrine/Caffeine and Pioglitazone: A Rationale for Combination Therapy of Obesity |
Resource links provided by NLM:
Drug Information available for:
Ephedrine Hydrochloride
Pseudoephedrine
Ephedrine sulfate
Pseudoephedrine hydrochloride
Pseudoephedrine sulfate
Pioglitazone
Pioglitazone hydrochloride
U.S. FDA Resources
Further study details as provided by Pennington Biomedical Research Center:
Primary Outcome Measures:
- Percent fat after 16 weeks treatment using a Hologic QDR 4500 DEXA.
Secondary Outcome Measures:
- UCP-1 gene expression by quantitative RT-PCR
- fat mass, lean mass
- visceral adiposity by multi-slice CT scanning
- resting metabolic rate and thermic effect of a single dose of ephedrine and caffeine
- adipose tissue gene expression profiling using oligonucleotide array
| Estimated Enrollment: | 96 |
| Study Start Date: | January 2003 |
| Estimated Study Completion Date: | November 2004 |
The sympathetic nervous system, via the intracellular messenger cAMP and MAPK activation, and thiazolidinediones via PPARγ control lipid metabolism have been implicated in body weight regulation. The present study was undertaken to determine whether the simultaneous activation of these two signaling systems might synergize to exert beneficial effects on the expression of key genes involved in lipid metabolism and mitochondrial biogenesis in subcutaneous fat in healthy, non-diabetic subjects. Fifty seven non-diabetic women and men were randomized into four groups: 1) placebo/placebo (PP); 2) ephedrine plus caffeine/placebo (ECP); 3) placebo/pioglitazone (PPio); 4) ephedrine plus caffeine/pioglitazone (ECPio). Adipose tissue samples were obtained after 12 weeks of treatment to determine gene expression by real time RT-PCR.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- generally healthy
- not pregnant or nursing
- using adequate contraception
- between 18 and 50 years of age
- BMI between 30 and 35 kg/m2
Exclusion Criteria:
- significant renal, cardiac, liver, lung or neurological disease
- high blood pressure
- diabetes
- prior use of thiazolidinedione
- prior use of beta-blockers alcohol or drug abuse
- history of thrombophlebitis, vascular or blood clotting disorders
- unwilling or unable to abstain from caffeinated beverages and alcohol prior to adipose tissue biopsy and metabolic rates measurements
- increased liver function test at baseline
- have metal objects that would interfere with the measurement of the body composition
- use drugs known to affect lipid metabolism, energy metabolism or body weight
- use herbal supplements containing ephedrine and/or caffeine
- take chronic medication, except hormone replacement or contraception
- are a woman unwilling to use effective contraception during the trial
- have heart disease or history of stroke
- have urinary symptoms from enlarged prostate
- have gained and or lost more than 10 pounds in the last 6 month
- have use a monoamine oxidase inhibitor medication in the last month
- have high or low thyroid function that has not been controlled in the normal range for at least 2 months
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00377975
Locations
| United States, Louisiana | |
| Pennington Biomedical Research Center | |
| Baton Rouge, Louisiana, United States, 70808 | |
Sponsors and Collaborators
Pennington Biomedical Research Center
Investigators
| Principal Investigator: | Steven R Smith, M.D. | Pennington Biomedical Research Center |
More Information
No publications provided by Pennington Biomedical Research Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00377975 History of Changes |
| Other Study ID Numbers: | PBRC#22021 |
| Study First Received: | September 17, 2006 |
| Last Updated: | September 17, 2006 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pennington Biomedical Research Center:
|
UCP-1 ephedrine caffeine pioglitazone |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders Overweight Body Weight Signs and Symptoms Caffeine Ephedrine Pseudoephedrine Pioglitazone Central Nervous System Stimulants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Purinergic P1 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Vasoconstrictor Agents Cardiovascular Agents Adrenergic Agents Nasal Decongestants Respiratory System Agents |
ClinicalTrials.gov processed this record on May 16, 2013