Clinical trial NCT01199692: Characterization of Metabolic Biomarkers in Varying Subjects
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Type 2 Diabetes
Lead sponsor: CPL Associates
Sponsor class: OTHER
First posted: 2010-09-13
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects of varying age, gender, ethnicity, body mass distribution, dietary habits, exercise habits, medication requirements and disease state burdens

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)

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Williamsville
country: United States
facility: Synergy Bariatrics, A Department of ECMC
state: New York
Study officials:
affiliation: CPL Associates, LLC
name: Scott Monte, PharmD
role: PRINCIPAL_INVESTIGATOR
References: