ObesityNCT01199692
Characterization of Metabolic Biomarkers in Varying Subjects
An observational study of Obesity and Type 2 Diabetes, run by CPL Associates at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Type 2 Diabetes
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects of varying age, gender, ethnicity, body mass distribution, dietary habits, exercise habits, medication requirements and disease state burdens
Who may be able to join
- Age =>18
- Weight =>110 pounds
Who cannot join
- Age <18
- Weight <110 pounds
- Pregnant
- Poor venous access or poor likelihood to adhere with study procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
Synergy Bariatrics, A Department of ECMC
Williamsville, New York, 14221
About this study
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
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.
Read the 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)
- Conditions
- Obesity, Type 2 Diabetes
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Age | Not described | |
| Gender | Not described | |
| Ethnicity | Not described | |
| Body Mass Distribution | Not described | |
| Dietary Habits | Not described | |
| Exercise Habits | Not described | |
| Medication Requirements | Not described | |
| Disease State Burden | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study startAug 2010
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CPL Associates
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Monte, CPL Associates
- Investigators
- Scott Monte, PharmD, Principal investigator, CPL Associates, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01199692
- Sponsor's protocol ID
- CPL201006A
- Status last verified
- Mar 2023
- First submitted
- 9 Sep 2010
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01199692
- Acronym / sponsor ID
- CPL201006A
- Conditions
- Obesity, Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- CPL AssociatesUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 13 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Age | – | – |
| Gender | – | – |
| Ethnicity | – | – |
| Body Mass Distribution | – | – |
| Dietary Habits | – | – |
| Exercise Habits | – | – |
| Medication Requirements | – | – |
| Disease State Burden | – | – |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects of varying age, gender, ethnicity, body mass distribution, dietary habits, exercise habits, medication requirements and disease state burdens
Key inclusion criteria (2 listed)
- Age =>18
- Weight =>110 pounds
Key exclusion criteria (4 listed)
- Age <18
- Weight <110 pounds
- Pregnant
- Poor venous access or poor likelihood to adhere with study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Monte, PharmD principal investigator
CPL Associates, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Type 2 Diabetes, run by CPL Associates at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.