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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list