Characterization of Metabolic Biomarkers in Varying Subjects

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.

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Key information

Conditions

Obesity Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Type 2 Diabetes

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Synergy Bariatrics, A Department of ECMC

Williamsville, New York, 14221, United States

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

CPL Associates

Other

Registry information

Official study 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

Important dates

Study start: 2010
Primary completion: 2022
Study completion: 2022
First posted: Sep 13, 2010
Registry last updated: Mar 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed