Individualised Tuebingen Lifestyle Intervention Program

ISRCTN ISRCTN48274837
DOI https://doi.org/10.1186/ISRCTN48274837
Secondary identifying numbers IGT Trial 01
Submission date
25/02/2010
Registration date
29/04/2010
Last edited
29/04/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Andreas Fritsche
Scientific

Otfried-Müller Straße 10
Tübingen
72076
Germany

Study information

Study designNon-randomised controlled interventional study
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Other
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleAn individualised lifestyle intervention program for the identification of prediabetic subjects with high risk phenotype: a non-randomised controlled interventional study
Study acronymiTULIP
Study objectivesIdentification of prediabetic subjects with high risk phenotype (fatty liver/insulin resistance or beta cell failure) for future lifestyle intervention.
Ethics approval(s)Tübingen Ethics Committee approved on the 10th January 2003 (ref: 422/2002)
Health condition(s) or problem(s) studiedDiabetes
InterventionControl arm:
1. Aimed weight reduction greater than 5%
2. Fat intake less than 30% of calories
3. Saturated fat intake less than 10% of calories
4. Fibre intake greater than 15 g/1000 kcal
5. Recommended physical activity greater than 3 hours/week
Six sessions in one year.

Intervention arm:
1. Aimed weight reduction greater than 5%
2. Fat intake less than 30% of calories
3. Saturated fat intake less than 10% of calories
4. Fibre intake greater than 15 g/1000 kcal
5. Supervised physical activity 8 hours/week
12 session in one year.

Total duration of intervention is 12 months. Follow-ups at 6 and 12 months. Phenotyping (oral glucose tolerance test [OGTT], magnetic resonance imaging [MRI] and magnetic resonance spectroscopy [MRS]) performed at baseline, 6 and 12 months.
Intervention typeOther
Primary outcome measureGlucose tolerance, measured at 6 months and 12 months
Secondary outcome measuresMeasured at 6 months and 12 months:
1. Beta cell function
2. Insulin sensitivity
3. Liver fat content
Overall study start date01/06/2010
Completion date31/12/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit75 Years
SexBoth
Target number of participants1000
Key inclusion criteria1. Men and women aged 18 - 75 years
2. Family history of diabetes (first degree relative)
3. Impaired glucose tolerance
4. Body mass index (BMI) greater than 27 kg/m^2
5. Prior gestational diabetes
Key exclusion criteria1. Aged below 18 years
2. Serious diseases, e.g., incurable cancer, untreated psychiatric disorders
3. Pregnancy
Date of first enrolment01/06/2010
Date of final enrolment31/12/2011

Locations

Countries of recruitment

  • Germany

Study participating centre

Otfried-Müller Straße 10
Tübingen
72076
Germany

Sponsor information

University Hospital Tuebingen (Universität Tübingen) (Germany)
Hospital/treatment centre

c/o Prof. Dr. med. H.U. Häring
Otfried Müller Straße 10
Tübingen
72076
Germany

Website http://www.medizin.uni-tuebingen.de/
ROR logo "ROR" https://ror.org/00pjgxh97

Funders

Funder type

Government

Federal Ministry for Education and Research (Bundeministerium für Bildung und Forschung [BMBF]) (Germany) (ref: DLR01GI0925)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan