Individualised Tuebingen Lifestyle Intervention Program
| ISRCTN | ISRCTN48274837 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48274837 |
| Protocol serial number | IGT Trial 01 |
| Sponsor | University Hospital Tuebingen (Universität Tübingen) (Germany) |
| Funder | Federal Ministry for Education and Research (Bundeministerium für Bildung und Forschung [BMBF]) (Germany) (ref: DLR01GI0925) |
- 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
Scientific
Otfried-Müller Straße 10
Tübingen
72076
Germany
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised controlled interventional study |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | An individualised lifestyle intervention program for the identification of prediabetic subjects with high risk phenotype: a non-randomised controlled interventional study |
| Study acronym | iTULIP |
| Study objectives | Identification 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) studied | 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 |
| Primary outcome measure(s) |
Glucose tolerance, measured at 6 months and 12 months |
| Key secondary outcome measure(s) |
Measured at 6 months and 12 months: |
| Completion date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | All |
| Target sample size at registration | 1000 |
| Key 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 |
| Key exclusion criteria | 1. Aged below 18 years 2. Serious diseases, e.g., incurable cancer, untreated psychiatric disorders 3. Pregnancy |
| Date of first enrolment | 01/06/2010 |
| Date of final enrolment | 31/12/2011 |
Locations
Countries of recruitment
- Germany
Study participating centre
Otfried-Müller Straße 10
Tübingen
72076
Germany
72076
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
