Characterization of Metabolic Biomarkers in Varying Subjects

Completed

• Conditions: Obesity; Type 2 Diabetes

• Registration Number: NCT01199692
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-09-09
• Study First Submitted QC: 2010-09-09
• Study First Posted: 2010-09-13
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-10
• Last Update Posted: 2023-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Synergy Bariatrics, A Department of ECMC; 🇺🇸 Williamsville, New York, United States