"Pecos" B-Adrenergic and PPAR-G Stimulation Upregulates Lipid Metabolism in Human Subcutaneous Fat - Full Text View

Sponsored by:	Pennington Biomedical Research Center
Information provided by:	Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:	NCT00377975

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 II

MedlinePlus related topics: Caffeine Obesity

Drug Information available for: Pioglitazone Pioglitazone hydrochloride Ephedrine Ephedrine Hydrochloride Pseudoephedrine hydrochloride Pseudoephedrine Sulfate Lipids 3,7-Dihydro-1,3,7-trimethyl-1H-purine-2,6-dione Caffeine citrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	Synergistic Induction of UCP-1 by Ephedrine/Caffeine and Pioglitazone: A Rationale for Combination Therapy of Obesity

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

Detailed Description:

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

Study ID Numbers:	PBRC#22021
Study First Received:	September 17, 2006
Last Updated:	September 17, 2006
ClinicalTrials.gov Identifier:	NCT00377975
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pennington Biomedical Research Center:

UCP-1
ephedrine
caffeine
pioglitazone

Study placed in the following topic categories:

Pseudoephedrine
Caffeine citrate
Obesity
Pioglitazone
Citric Acid
Overweight
Naphazoline
Body Weight
Oxymetazoline

Signs and Symptoms
Guaifenesin
Phenylephrine
Nutrition Disorders
Overnutrition
Ephedrine
Caffeine
Phenylpropanolamine

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Sympathomimetics
Physiological Effects of Drugs
Anti-Asthmatic Agents
Enzyme Inhibitors
Central Nervous System Stimulants
Cardiovascular Agents

Pharmacologic Actions
Nasal Decongestants
Hypoglycemic Agents
Phosphodiesterase Inhibitors
Autonomic Agents
Therapeutic Uses
Vasoconstrictor Agents
Peripheral Nervous System Agents
Bronchodilator Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009