Metabolic SyndromeLUPSNCT01313156
LUPS-Lipids and Glucose Under Prospective Surveillance
An observational study of Metabolic Syndrome and Type 2 Diabetes, run by Asklepios proresearch at 2 sites in Germany.
Trial summary
Prospective, non-randomized cohort study to analyse genetic variations, dietary patterns, perceived stress and anxiety and early changes in lipid metabolism leading to the metabolic syndrome and type 2 diabetes Read more about this study
- Who is it for?
- Ages 25 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Type 2 Diabetes
- How many people
- 1,962 participants
- Where
- 2 sitesGermany
- Study dates
- Nov 2008to Aug 2019
- 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 25 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: so-called "Healthy-Workers", aged 25-60years, of Lufthansa-Technik, Hamburg, Germany, who voluntarily aggreed to participate in the study.
Who may be able to join
- 25-60 years men and women willing to give consent
Who cannot join
- diabetes (type 1 or 2)
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Asklepios Klinik St.Georg
Hamburg, 20099
Universitätsklinikum Eppendorf
Hamburg, 20246
About this study
Official title: Lipids and Glucose Under Prospective Surveillance
Prospective, non-randomized cohort study to analyse genetic variations, dietary patterns, perceived stress and anxiety and early changes in lipid metabolism leading to the metabolic syndrome and type 2 diabetes
Read the detailed description
The LUPS-study is a collaboration between Asklepios Clinics Hamburg GmbH and University Clinic Hamburg Eppendorf, Germany. This study is assessing a multitude of serum biomarkers, anthropometrics, dietary habits, physical activity, perceived stress along with genetic information from "healthy workers" (25-60years) to better understand phenotype-genotype associations leading to MetS and type 2 diabetes.
- Conditions
- Metabolic Syndrome, Type 2 Diabetes
- Keywords
- Metabolic Syndrome, Syndrome X, MetS,, Type 2 Diabetes
- Medical subject headings
- Metabolic Syndrome, Diabetes Mellitus, Type 2, Microvascular Angina
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic Syndrome, Type 2 Diabetes
assessing risk factors, e.g. HDL, BMI, Blood Pressure, FPG
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2011 (estimated)
- Study startNov 2008
- Primary completionAug 2019
- Study completionAug 2019
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 Metabolic SyndromeStudies 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
- Prospective
- Enrolment
- 1,962 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asklepios proresearch
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- City of Hamburg, Universitätsklinikum Hamburg-Eppendorf
- Responsible party
- Sponsor
- Investigators
- Dirk Mueller-Wieland, Prof., MD, Principal investigator, Asklepios Klinik St.Georg, Hamburg, GermanyKarl Wegscheider, Prof., PHD, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01313156
- Sponsor's protocol ID
- AKS#1833
- Acronym
- LUPS
- Status last verified
- Apr 2018
- First submitted
- 10 Mar 2011
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Muller-Wieland D, Altenburg C, Becher H, Burchard J, Frisch A, Gebhard J, Haas J, Harth V, Heeren J, Hengelbrock J, von Karais M, Knebel B, Kotzka J, Lowe B, Marx N, Pinnschmidt H, Preisser A, Rose M, Sawitzky-Rose B, Scheja L, Terschuren C, Toller M, Vettorazzi E, Wegscheider K. Development of the Metabolic Syndrome: Study Design and Baseline Data of the Lufthansa Prevention Study (LUPS), A Prospective Observational Cohort Survey. Exp Clin Endocrinol Diabetes. 2020 Dec;128(12):777-787. doi: 10.1055/a-0767-6361. Epub 2018 Nov 26.
PubMed 30477037
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipids and Glucose Under Prospective Surveillance
- ClinicalTrials.gov ID
- NCT01313156
- Acronym / sponsor ID
- LUPS / AKS#1833
- Conditions
- Metabolic Syndrome, Type 2 Diabetes
- Keywords
- Metabolic Syndrome, Syndrome X, MetS,, Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,962 participants (actual)
- Lead sponsor
- Asklepios proresearchIndustry (pharma, biotech, devices)
- Collaborators
- City of Hamburg, Universitätsklinikum Hamburg-Eppendorf
- Study start
- Nov 2008
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 11 Mar 2011 (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.
Prospective, non-randomized cohort study to analyse genetic variations, dietary patterns, perceived stress and anxiety and early changes in lipid metabolism leading to the metabolic syndrome and type 2 diabetes
Detailed description
The LUPS-study is a collaboration between Asklepios Clinics Hamburg GmbH and University Clinic Hamburg Eppendorf, Germany. This study is assessing a multitude of serum biomarkers, anthropometrics, dietary habits, physical activity, perceived stress along with genetic information from "healthy workers" (25-60years) to better understand phenotype-genotype associations leading to MetS and type 2 diabetes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- so-called "Healthy-Workers", aged 25-60years, of Lufthansa-Technik, Hamburg, Germany, who voluntarily aggreed to participate in the study.
Key inclusion criteria (1 listed)
- 25-60 years men and women willing to give consent
Key exclusion criteria (1 listed)
- diabetes (type 1 or 2)
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
Metabolic Syndrome, Type 2 Diabetes
Time frame: 10 years
assessing risk factors, e.g. HDL, BMI, Blood Pressure, FPG
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 9 Aug 2019.
- Derived from this study: PubMed 30477037Muller-Wieland D, Altenburg C, Becher H, Burchard J, Frisch A, Gebhard J, Haas J, Harth V, Heeren J, Hengelbrock J, von Karais M, Knebel B, Kotzka J, Lowe B, Marx N, Pinnschmidt H, Preisser A, Rose M, Sawitzky-Rose B, Scheja L, Terschuren C, Toller M, Vettorazzi E, Wegscheider K. Development of the Metabolic Syndrome: Study Design and Baseline Data of the Lufthansa Prevention Study (LUPS), A Prospective Observational Cohort Survey. Exp Clin Endocrinol Diabetes. 2020 Dec;128(12):777-787. doi: 10.1055/a-0767-6361. Epub 2018 Nov 26.
Related trials for Metabolic Syndrome
RecruitingObservational study
Cancer in Inherited Bone Marrow Failure Syndromes
Diamond Blackfan Anemia, Dyskeratosis Congenita
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
RecruitingPhase 2/3
A Study in Pediatric Participants With Congenital Adrenal Hyperplasia (Balance-CAH)
Congenital Adrenal Hyperplasia, Classic Congenital Adrenal Hyperplasia
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
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.
Dirk Mueller-Wieland, Prof., MD principal investigator
Asklepios Klinik St.Georg, Hamburg, Germany
Karl Wegscheider, Prof., PHD principal investigator
Universitätsklinikum Hamburg-Eppendorf
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome and Type 2 Diabetes, run by Asklepios proresearch at 2 sites in Germany.
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 1 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 9 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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.
What does the primary outcome measure?
Metabolic Syndrome, Type 2 Diabetes (time frame: 10 years). 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 NCT01313156, 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 9 Aug 2019.