Obesity, MorbidNCT00957957
Gut Hormone Profiling in Obese Patients With Type 2 Diabetes (MK-0000-134)
An observational study of Obesity, Morbid and Diabetes Mellitus Type 2, run by Merck Sharp & Dohme LLC.
Trial summary
This study will examine changes in various gut-derived hormones in obese type 2 diabetic patients before and after elective bariatric surgery. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Obesity, Morbid, Diabetes Mellitus Type 2
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Nov 2014
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Morbidly obese type 2 diabetic patients
Who may be able to join
- Documented type 2 diabetes with total disease duration ≤10 years
- BMI of at least 35 kg/m^2
- Patient is a surgical candidate for either RYGBP, GBS or vertical sleeve gastrectomy (VSG)
Who cannot join
- Any illness that might confound the results of the study or pose additional risk to the patient by participation
- History of stroke, seizures, or other major neurological disorder
- History of cancer
- Patient uses or has used any medication that can alter body weight
- Patient is unwilling or unable to follow study procedures
About this study
Official title: Gut Hormone Profiling in Peripheral Blood After Bariatric Surgery in Obese Patients With Type 2 Diabetes
This study will examine changes in various gut-derived hormones in obese type 2 diabetic patients before and after elective bariatric surgery.
- Conditions
- Obesity, Morbid, Diabetes Mellitus Type 2
- Medical subject headings
- Obesity, Morbid, 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 |
|---|---|---|
| 1 | Participants having elective Roux-en-Y gastric bypass surgery (RYGBP) | |
| 2 | Participants having elective gastric banding surgery (GB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in PYY (Peptide YY) measured by ELISA 4 weeks after RYGBP
Measured: Baseline and Week 4
Secondary outcomes (1)
Change from baseline in PYY measured by dMS 4 weeks after RYGBP
Measured: Baseline and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2009 (estimated)
- Study startFeb 2010
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00957957
- Sponsor's protocol ID
- 0000-134
- Other IDs
- 2009_002
- Status last verified
- Jan 2016
- First submitted
- 11 Aug 2009
- Last updated
- 20 Jan 2016
- Results posted
- No
Publications
Shankar SS, Mixson LA, Chakravarthy M, Chisholm R, Acton AJ, Jones R, Mattar SG, Miller DL, Petry L, Beals CR, Stoch SA, Kelley DE, Considine RV. Metabolic improvements following Roux-en-Y surgery assessed by solid meal test in subjects with short duration type 2 diabetes. BMC Obes. 2017 Mar 1;4:10. doi: 10.1186/s40608-017-0149-1. eCollection 2017.
PubMed 28265415
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Hormone Profiling in Peripheral Blood After Bariatric Surgery in Obese Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00957957
- Acronym / sponsor ID
- 0000-134
- Conditions
- Obesity, Morbid, Diabetes Mellitus Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 13 Aug 2009 (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.
This study will examine changes in various gut-derived hormones in obese type 2 diabetic patients before and after elective bariatric surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Participants having elective Roux-en-Y gastric bypass surgery (RYGBP) |
| 2 | – | –Participants having elective gastric banding surgery (GB) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Morbidly obese type 2 diabetic patients
Key inclusion criteria (3 listed)
- Documented type 2 diabetes with total disease duration ≤10 years
- BMI of at least 35 kg/m^2
- Patient is a surgical candidate for either RYGBP, GBS or vertical sleeve gastrectomy (VSG)
Key exclusion criteria (5 listed)
- Any illness that might confound the results of the study or pose additional risk to the patient by participation
- History of stroke, seizures, or other major neurological disorder
- History of cancer
- Patient uses or has used any medication that can alter body weight
- Patient is unwilling or unable to follow 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
Change from baseline in PYY (Peptide YY) measured by ELISA 4 weeks after RYGBP
Time frame: Baseline and Week 4
1 secondary outcome
Change from baseline in PYY measured by dMS 4 weeks after RYGBP
Time frame: Baseline and week 4
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 20 Jan 2016.
- Derived from this study: PubMed 28265415Shankar SS, Mixson LA, Chakravarthy M, Chisholm R, Acton AJ, Jones R, Mattar SG, Miller DL, Petry L, Beals CR, Stoch SA, Kelley DE, Considine RV. Metabolic improvements following Roux-en-Y surgery assessed by solid meal test in subjects with short duration type 2 diabetes. BMC Obes. 2017 Mar 1;4:10. doi: 10.1186/s40608-017-0149-1. eCollection 2017.
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Morbid and Diabetes Mellitus Type 2, run by Merck Sharp & Dohme LLC.
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 3 inclusion and 5 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 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
Change from baseline in PYY (Peptide YY) measured by ELISA 4 weeks after RYGBP (time frame: Baseline and Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00957957, which also lists 1 linked publication.
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 20 Jan 2016.