Characterization of Metabolic Biomarkers in Varying Subjects

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01199692
Recruitment Status : Recruiting
First Posted : September 13, 2010
Last Update Posted : July 24, 2017
Information provided by (Responsible Party):
Scott Monte, CPL Associates

Brief Summary:
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 or disease
Obesity Type 2 Diabetes

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)

Study Type : Observational
Estimated Enrollment : 250 participants
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
Study Start Date : August 2010
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Body Mass Distribution
Dietary Habits
Exercise Habits
Medication Requirements
Disease State Burden

Biospecimen Retention:   Samples With DNA
Blood, stool, urine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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

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 identifier (NCT number): NCT01199692

Contact: Scott Monte, Pharm.D. 716-713-0368

United States, New York
Synergy Bariatrics, A Department of ECMC Recruiting
Williamsville, New York, United States, 14221
Contact: Scott Monte, Pharm.D.    716-565-3990   
Sponsors and Collaborators
CPL Associates
Principal Investigator: Scott Monte, PharmD CPL Associates, LLC

Responsible Party: Scott Monte, Program Director, CPL Associates Identifier: NCT01199692     History of Changes
Other Study ID Numbers: CPL201006A
First Posted: September 13, 2010    Key Record Dates
Last Update Posted: July 24, 2017
Last Verified: July 2017