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Characterization of Metabolic Biomarkers in Varying Subjects

Sponsor
CPL Associates (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01199692
Collaborator
(none)
250
Enrollment
1
Location
182
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated 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 :
    Aug 1, 2010
    Anticipated Primary Completion Date :
    Aug 1, 2024
    Anticipated Study Completion Date :
    Oct 1, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    Age
    Gender
    Ethnicity
    Body Mass Distribution
    Dietary Habits
    Exercise Habits
    Medication Requirements
    Disease State Burden

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 100 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      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

      Locations

      Site City State Country Postal Code
      1 Synergy Bariatrics, A Department of ECMC Williamsville New York United States 14221

      Sponsors and Collaborators

      • CPL Associates

      Investigators

      • Principal Investigator: Scott Monte, PharmD, CPL Associates, LLC

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Scott Monte, Program Director, CPL Associates
      ClinicalTrials.gov Identifier:
      NCT01199692
      Other Study ID Numbers:
      • CPL201006A
      First Posted:
      Sep 13, 2010
      Last Update Posted:
      Oct 14, 2021
      Last Verified:
      Oct 1, 2021

      Study Results

      No Results Posted as of Oct 14, 2021