Characterization of Metabolic Biomarkers in Varying Subjects
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 3/1/2019 |
| Start Date: | August 2010 |
| End Date: | October 2025 |
| Contact: | Scott Monte, Pharm.D. |
| Email: | smonte@cplassociates.com |
| Phone: | 716-713-0368 |
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.
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.
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)
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)
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
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