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

This study has been completed.
Sponsor:
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Pioglitazone
Caffeine
Ephedrine
Pseudoephedrine
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Stimulants
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
Bronchodilator Agents

ClinicalTrials.gov processed this record on September 18, 2014