Condition category
Nutritional, Metabolic, Endocrine
Date applied
25/02/2010
Date assigned
29/04/2010
Last edited
29/04/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Andreas Fritsche

ORCID ID

Contact details

Otfried-Müller Straße 10
Tübingen
72076
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IGT Trial 01

Study information

Scientific title

An individualised lifestyle intervention program for the identification of prediabetic subjects with high risk phenotype: a non-randomised controlled interventional study

Acronym

iTULIP

Study hypothesis

Identification of prediabetic subjects with high risk phenotype (fatty liver/insulin resistance or beta cell failure) for future lifestyle intervention.

Ethics approval

Tübingen Ethics Committee approved on the 10th January 2003 (ref: 422/2002)

Study design

Non-randomised controlled interventional study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Diabetes

Intervention

Control 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 type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Glucose tolerance, measured at 6 months and 12 months

Secondary outcome measures

Measured at 6 months and 12 months:
1. Beta cell function
2. Insulin sensitivity
3. Liver fat content

Overall trial start date

01/06/2010

Overall trial end date

31/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1000

Participant exclusion criteria

1. Aged below 18 years
2. Serious diseases, e.g., incurable cancer, untreated psychiatric disorders
3. Pregnancy

Recruitment start date

01/06/2010

Recruitment end date

31/12/2011

Locations

Countries of recruitment

Germany

Trial participating centre

Otfried-Müller Straße 10
Tübingen
72076
Germany

Sponsor information

Organisation

University Hospital Tuebingen (Universität Tübingen) (Germany)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

http://www.medizin.uni-tuebingen.de/

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes