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"Pecos" B-adrenergic and PPAR-G Stimulation Upregulates Lipid Metabolism in Human Subcutaneous Fat

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00377975
First Posted: September 19, 2006
Last Update Posted: January 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Steven Smith, Pennington Biomedical Research Center
  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
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:


Further study details as provided by Steven Smith, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Steven Smith, Associate Professor, Adjunct, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT00377975     History of Changes
Other Study ID Numbers: PBRC 22021
First Submitted: September 17, 2006
First Posted: September 19, 2006
Last Update Posted: January 25, 2016
Last Verified: January 2016

Keywords provided by Steven Smith, Pennington Biomedical Research Center:
UCP-1
ephedrine
caffeine
pioglitazone

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Pioglitazone
Caffeine
Ephedrine
Pseudoephedrine
Hypoglycemic Agents
Physiological Effects of Drugs
Central Nervous System Stimulants
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
Adrenergic Agents
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents
Nasal Decongestants