Characterization of Metabolic Biomarkers in Subjects of Varying Age, Gender, Ethnicity, Body Mass Distribution, Dietary Habits, Exercise Habits, Medication Requirements, and Disease State Burden
| City: |
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Cheektowaga |
| State: |
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New York |
| Zip Code: |
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14225 |
| Conditions: |
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Obesity - Type 2 Diabetes |
| Purpose: |
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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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| Study Summary: |
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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)
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| Criteria: |
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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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| NCT ID: |
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NCT01199692 |
| Primary Contact: |
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Principal Investigator
Scott Monte, PharmD
CPL Associates, LLC
Scott Monte, Pharm.D.
Phone: 716-839-4931 ext. 208
Email: smonte@cplassociates.com
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| Backup Contact: |
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N/A |
| Location Contact: |
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Cheektowaga, New York 14225
United States
Scott Monte, Pharm.D.
Phone: 716-839-4931
Email: smonte@cplassociates.com
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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