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

January 22, 2016 updated by: Steven Smith, Pennington Biomedical Research Center

Synergistic Induction of UCP-1 by Ephedrine/Caffeine and Pioglitazone: A Rationale for Combination Therapy of Obesity

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

96

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Percent fat after 16 weeks treatment using a Hologic QDR 4500 DEXA.

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pennington Biomedical Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Study Completion

November 1, 2004

Study Registration Dates

First Submitted

September 17, 2006

First Submitted That Met QC Criteria

September 17, 2006

First Posted (Estimate)

September 19, 2006

Study Record Updates

Last Update Posted (Estimate)

January 25, 2016

Last Update Submitted That Met QC Criteria

January 22, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBRC 22021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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