NCT01199692

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 9, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2010

Completed
12.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 14, 2023

Status Verified

March 1, 2023

Enrollment Period

12.4 years

First QC Date

September 9, 2010

Last Update Submit

March 10, 2023

Conditions

ObesityType 2 Diabetes

Study Arms (8)

Age

Gender

Ethnicity

Body Mass Distribution

Dietary Habits

Exercise Habits

Medication Requirements

Disease State Burden

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects of varying age, gender, ethnicity, body mass distribution, dietary habits, exercise habits, medication requirements and disease state burdens

You may qualify if:

  • Age =\>18
  • Weight =\>110 pounds

You may not qualify if:

  • Age \<18
  • Weight \<110 pounds
  • Pregnant
  • Poor venous access or poor likelihood to adhere with study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Synergy Bariatrics, A Department of ECMC

Williamsville, New York, 14221, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, stool, urine

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Officials

  • Scott Monte, PharmD

    CPL Associates, LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Program Director

Study Record Dates

First Submitted

September 9, 2010

First Posted

September 13, 2010

Study Start

August 1, 2010

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

March 14, 2023

Record last verified: 2023-03

Locations

US(1)