Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2025-12-28 @ 1:36 PM
Study NCT ID:
NCT01199692
Status:
COMPLETED
Last Update Posted:
2023-03-14
First Post:
2010-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characterization of Metabolic Biomarkers in Varying Subjects
Sponsor:
CPL Associates
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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)
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: