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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01199692
Other study ID # CPL201006A
Secondary ID
Status Recruiting
Phase N/A
First received September 9, 2010
Last updated July 21, 2017
Start date August 2010
Est. completion date October 2018

Study information

Verified date July 2017
Source CPL Associates
Contact Scott Monte, Pharm.D.
Phone 716-713-0368
Email smonte@cplassociates.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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)


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date October 2018
Est. primary completion date August 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
United States Synergy Bariatrics, A Department of ECMC Williamsville New York

Sponsors (1)

Lead Sponsor Collaborator
CPL Associates

Country where clinical trial is conducted

United States, 

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