Obese PatientsRESISTINNCT02934737
Role of markErs in the progreSsion of dIabeteS in Obese paTIeNts
An observational study of Obese Patients, run by University of Pavia.
Trial summary
Obese patients will be enrolled from 2006 to 2014. The progression of diabetes mellitus will be observed (if any). Anthropometric and biochemical parameters will be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Obese Patients
- What is being tested?
- Progression of diabetes
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Nov 2018
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Output patients with obesity
Who may be able to join
- Obesity (body mass index >/= 30 Kg/m2
- Normal blood glucose (glycemia < 100 mg/dl)
Who cannot join
- No exclusion criteria
About this study
Official title: Role of Some Markers in the Progression of Diabetes in Obese Patients: a 8-year Observational Study
Obese patients will be enrolled from 2006 to 2014. The progression of diabetes mellitus will be observed (if any). Anthropometric and biochemical parameters will be evaluated.
- Conditions
- Obese Patients
- Being tested
- Progression of diabetes
- Keywords
- Obesity, Diabetes Mellitus
- Medical subject headings
- Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progression of diabetesOther
Also called Variations of biochemical parameters
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of diabetes
evaluation of glycemia during 8 years
Measured: 8 years
Anthropometric parameters
Weight
Measured: 8 years
Anthropometric parameters
Waist circumference; hip circumference; abdominal circumference
Measured: 8 years
Markers of progression of diabetes
Adiponectin
Measured: 8 years
Markers of progression of diabetes
Resistin
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionNov 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obese PatientsStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Derosa, University of Pavia
- Investigators
- Giuseppe Derosa, MD, PhD, FESC, Principal investigator, University of Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02934737
- Sponsor's protocol ID
- 20160004418
- Acronym
- RESISTIN
- Status last verified
- Nov 2020
- First submitted
- 12 Oct 2016
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Some Markers in the Progression of Diabetes in Obese Patients: a 8-year Observational Study
- ClinicalTrials.gov ID
- NCT02934737
- Acronym / sponsor ID
- RESISTIN / 20160004418
- Conditions
- Obese Patients
- Keywords
- Obesity, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of PaviaUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 17 Oct 2016 (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.
Obese patients will be enrolled from 2006 to 2014. The progression of diabetes mellitus will be observed (if any). Anthropometric and biochemical parameters will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Output patients with obesity
Key inclusion criteria (2 listed)
- Obesity (body mass index >/= 30 Kg/m2
- Normal blood glucose (glycemia < 100 mg/dl)
Key exclusion criteria (1 listed)
- No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progression of diabetesAlso: Variations of biochemical parameters | Other | – |
Primary outcome
Progression of diabetes
Time frame: 8 years
evaluation of glycemia during 8 years
Anthropometric parameters
Time frame: 8 years
Weight
Anthropometric parameters
Time frame: 8 years
Waist circumference; hip circumference; abdominal circumference
Markers of progression of diabetes
Time frame: 8 years
Adiponectin
Markers of progression of diabetes
Time frame: 8 years
Resistin
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 10 Nov 2020.
- Individual participant dataSharing planned: No
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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.
Giuseppe Derosa, MD, PhD, FESC principal investigator
University of Pavia
Questions about this trial
What is this clinical trial studying?
An observational study of Obese Patients, run by University of Pavia.
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 1 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 10 Nov 2020. 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?
Progression of diabetes (time frame: 8 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 10 Nov 2020.