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Characterization of Metabolic Biomarkers in Varying Subjects

This study is currently recruiting participants.
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
History of Changes
  Purpose

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.


Condition
Obesity
Type 2 Diabetes

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Characterization of Metabolic Biomarkers in Subjects of Varying Age, Gender, Ethnicity, Body Mass Distribution, Dietary Habits, Exercise Habits, Medication Requirements, and Disease State Burden

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by CPL Associates:

Biospecimen Retention:   Samples With DNA

Blood, stool, urine


Estimated Enrollment: 250
Study Start Date: August 2010
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Age
Gender
Ethnicity
Body Mass Distribution
Dietary Habits
Exercise Habits
Medication Requirements
Disease State Burden

Detailed Description:

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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01199692

Contacts
Contact: Scott Monte, Pharm.D. 716-839-4931 ext 208 smonte@cplassociates.com

Locations
United States, New York
VascuFlo Center Recruiting
Cheektowaga, New York, United States, 14225
Contact: Scott Monte, Pharm.D.     716-839-4931 ext 208     smonte@cplassociates.com    
Sponsors and Collaborators
CPL Associates
Investigators
Principal Investigator: Scott Monte, PharmD CPL Associates, LLC
  More Information

No publications provided

Responsible Party: Scott Monte, Program Director, CPL Associates
ClinicalTrials.gov Identifier: NCT01199692     History of Changes
Other Study ID Numbers: CPL201006A
Study First Received: September 9, 2010
Last Updated: August 1, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Obesity
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013