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

September 9, 2010
September 13, 2010
July 24, 2017
August 2010
August 2018   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01199692 on Archive Site
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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 Model: Case-Control
Time Perspective: Prospective
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Retention:   Samples With DNA
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
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  • Age
  • Gender
  • Ethnicity
  • Body Mass Distribution
  • Dietary Habits
  • Exercise Habits
  • Medication Requirements
  • Disease State Burden
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
October 2018
August 2018   (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
Sexes Eligible for Study: All
18 Years to 100 Years   (Adult, Senior)
Contact: Scott Monte, Pharm.D. 716-713-0368
United States
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Scott Monte, CPL Associates
CPL Associates
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Principal Investigator: Scott Monte, PharmD CPL Associates, LLC
CPL Associates
July 2017