NCT01313156

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,962

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2008

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

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

November 1, 2008

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 11, 2011

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

August 9, 2019

Status Verified

April 1, 2018

Enrollment Period

10.8 years

First QC Date

March 10, 2011

Last Update Submit

August 8, 2019

Conditions

Metabolic SyndromeType 2 Diabetes

Keywords

Metabolic Syndrome, Syndrome X, MetS,Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Metabolic Syndrome, Type 2 Diabetes

    assessing risk factors, e.g. HDL, BMI, Blood Pressure, FPG

    10 years

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

so-called "Healthy-Workers", aged 25-60years, of Lufthansa-Technik, Hamburg, Germany, who voluntarily aggreed to participate in the study.

You may qualify if:

  • years men and women willing to give consent

You may not qualify if:

  • diabetes (type 1 or 2)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Asklepios Klinik St.Georg

Hamburg, 20099, Germany

Location

Universitätsklinikum Eppendorf

Hamburg, 20246, Germany

Location

Related Publications (1)

  • 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.

    PMID: 30477037DERIVED

MeSH Terms

Conditions

Metabolic SyndromeDiabetes Mellitus, Type 2Microvascular Angina

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes MellitusEndocrine System DiseasesAngina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Dirk Mueller-Wieland, Prof., MD

    Asklepios Klinik St.Georg, Hamburg, Germany

    PRINCIPAL INVESTIGATOR

  • Karl Wegscheider, Prof., PHD

    Universitätsklinikum Hamburg-Eppendorf, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2011

First Posted

March 11, 2011

Study Start

November 1, 2008

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

August 9, 2019

Record last verified: 2018-04

Locations

DE(2)