Characterization of Metabolic Biomarkers in Varying Subjects

March 10, 2023 updated by: Scott Monte, CPL Associates

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Williamsville, New York, United States, 14221
        • Synergy Bariatrics, A Department of ECMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Age
Gender
Ethnicity
Body Mass Distribution
Dietary Habits
Exercise Habits
Medication Requirements
Disease State Burden

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CPL Associates

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

September 9, 2010

First Submitted That Met QC Criteria

September 9, 2010

First Posted (Estimate)

September 13, 2010

Study Record Updates

Last Update Posted (Actual)

March 14, 2023

Last Update Submitted That Met QC Criteria

March 10, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • CPL201006A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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