Characterization of Metabolic Biomarkers in Varying Subjects

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by CPL Associates
Sponsor:
Information provided by (Responsible Party):
Scott Monte, CPL Associates
ClinicalTrials.gov Identifier:
NCT01199692
First received: September 9, 2010
Last updated: August 1, 2012
Last verified: August 2012

September 9, 2010
August 1, 2012
August 2010
August 2016   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01199692 on ClinicalTrials.gov Archive Site
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Not Provided
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Characterization of Metabolic Biomarkers in Varying Subjects
Characterization of Metabolic Biomarkers in Subjects of Varying Age, Gender, Ethnicity, Body Mass Distribution, Dietary Habits, Exercise Habits, Medication Requirements, and Disease State Burden

Traditional dietary, lifestyle, behavioral and pharmacologic treatment strategies have proven relatively ineffective for treating obesity, and once metabolic abnormalities such as Type 2 Diabetes (T2D) develop, definitive strategies to prevent major cardiovascular events remain elusive. More positively, the identification of a scientific resolution for obesity and T2D in the short-term is not outside the bounds of reality. Because the complexity of metabolic regulation is likely to include already characterized biomarkers, as well as other unidentified factors, it is logical to sample subjects of various ages, gender, ethnicity, body mass distribution, dietary habits, exercise habits, medication requirements, and disease states to discover associations and pathways related to the restoration of normal metabolism.

As an observational study design, study investigators will prospectively identify potential subjects from various primary care and/or specialty care clinics in Western New York. Prior to the commencement of any study procedures, subjects will document informed consent and acknowledgement of HIPPA rights. Following approval from their practitioner, subjects may be asked on multiple occasions to complete or undergo any or all of the following types of study procedures:

  • Medical record review and follow-up
  • Fasting blood sample (volume limitations stipulated within)
  • Pre-meal, during meal, and post-meal blood sample (volume limits within)
  • Short-term and/or long-term dietary intervention (MD approved)
  • Short-term and/or long-term exercise intervention (MD approved)
  • Blood glucose log
  • Food and exercise diaries
  • Pre- and post-medication blood sampling (neutraceutical or Rx products)
  • 24-hour urine sampling
  • Spot urine sampling
  • Stool microbiologic sampling
  • Intestinal microbiologic sampling (gastric bypass subjects only)
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood, stool, urine

Non-Probability Sample

Subjects of varying age, gender, ethnicity, body mass distribution, dietary habits, exercise habits, medication requirements and disease state burdens

  • Obesity
  • Type 2 Diabetes
Not Provided
  • Age
  • Gender
  • Ethnicity
  • Body Mass Distribution
  • Dietary Habits
  • Exercise Habits
  • Medication Requirements
  • Disease State Burden
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
October 2016
August 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age =>18
  • Weight =>110 pounds

Exclusion Criteria:

  • Age <18
  • Weight <110 pounds
  • Pregnant
  • Poor venous access or poor likelihood to adhere with study procedures
Both
18 Years and older
Yes
Contact: Scott Monte, Pharm.D. 716-839-4931 ext 208 smonte@cplassociates.com
United States
 
NCT01199692
CPL201006A
No
Scott Monte, CPL Associates
CPL Associates
Not Provided
Principal Investigator: Scott Monte, PharmD CPL Associates, LLC
CPL Associates
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP