Diabetes Mellitus Type 2PLISNCT01947595
Individualized Lifestyle Intervention in Subjects With Prediabetes
A study testing intensified lifestyle intervention, normal lifestyle intervention and Single lifestyle advice in people with Diabetes Mellitus Type 2, run by University Hospital Tuebingen at 7 sites in Germany.
Trial summary
The purpose of this prospective randomized multicenter intervention study is to determine whether in the prevention of Diabetes an intensified lifestyle intervention is superior to a conventional lifestyle intervention in high risk non-Responder subjects. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- intensified lifestyle intervention, normal lifestyle intervention and Single lifestyle advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,145 participants
- Where
- 7 sitesGermany
- Study dates
- Mar 2012to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- impaired fasting glucose (IFG)
- fasting blood glucose 99-126 mg/dl
- and/or
- impaired glucose tolerance (IGT)
- 75 g OGTT 120 minutes: 139-200 mg/dl
Who cannot join
- current pregnancy or breastfeeding
- BMI > 45 kg/m²
- Diabetes mellitus Typ 1 or 2
- serious disease e.g symptomatic coronary heart disease
- serious symptomatic malignant disease (weight loss > 10% within the last 6 month)
- severe liver or kidney disease ( an increase in transaminases > 3 times than the upper limit of the standardized range, GFR < 50 ml/min/1,73m²)
Show all 36Show fewer
- systemic infection (CRP > 1 mg/dl)
- severe mental illness
- drug abuse
- treatment with steroids
- potentially incompliant subjects
- any kind of metal in or on the body:
- cardiac pacemakers
- prosthetic heart valves
- metal prosthesis
- magnetic implanted metallic parts
- contraceptive coil
- metal fragments/ grenade shrapnel
- fixed braces
- acupuncture needles
- insulin pump
- intraport etc.
- Field strength > 3 Tesla further tattoos, permanent make-up
- persons with limited thermosensory or heightened sensitivity to heating
- persons where cardiovascular disease cannot be ruled out by examination
- persons with heightened sensitivity to loud noise or diseases of the ear
- used closed whole body scanner: claustrophobia
- Additional for spirometry
- acute coronary syndrome
- higher cardiac arrhythmia
- decompensated heart failure
- acute carditis
- pulmonary embolism
- acute deep leg vein thrombosis ( phlebothrombosis)
- hyperthyroidism (TSH)
- hypokalemia
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Germany7 sites
Deutsches Institut für Ernährungsforschung / Charité Berlin
Berlin
University Hospital Dresden
Dresden
Deutsches Diabetes Zentrum
Düsseldorf, 40225
Technische Universität München (TU Munich)
Munich, 80333
Helmholtz Zentrum München
Munich, 85764
Ludwig-Maximilians-University
Munich
University Hospital Tübingen
Tübingen, 72076
About this study
Official title: Prediabetes Lifestyle Intervention Study
The purpose of this prospective randomized multicenter intervention study is to determine whether in the prevention of Diabetes an intensified lifestyle intervention is superior to a conventional lifestyle intervention in high risk non-Responder subjects. Further, the intensive phenotyping to determine subgroups with an increased risk for diabetes enables an individualized prevention and therapy of type 2 diabetes mellitus.
Read the detailed description
The study start with an intensive phenotyping at baseline (initial examination) to determine subjects with prediabetes. These high risk non-Responder are randomized in two arms (intensified vs normal lifestyle intervention)with equal number of subjects (n=250). The results are compared with each other at the end of the study.
The low risk Responder are randomized in two arms (normal vs. once lifestyle intervention = control group) with equal number of subjects (n=250).
After the screening at baseline the 12 month lifestyle intervention starts for lifestyle intervention groups. The different therapy groups are formed as described before. The subjects with intensified lifestyle intervention get 16 consultations, the subjects with normal lifestyle intervention get 8 consultations, the subjects of the control group get one consultation to learn more about a healthier lifestyle. During the whole study there is a continuous supervision from physician and nutritional advisers and the subjects have to document a nutrition and an exercise protocol as well as subjective measurements. At baseline, after 24 weeks and at follow up 1, 2 and 3 years later there is an elaborate metabolic characterization of all subjects (also the Responder groups) a 75 g venous oral glucose tolerance test (OGTT) as well as an analysis of the distribution of body fat confirmed by MR-Imaging and proton magnetic resonance spectroscopy by 3 T whole body imager.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- intensified lifestyle intervention, normal lifestyle intervention, Single lifestyle advice
- Keywords
- diabetes mellitus type 2, impaired glucose tolerance, lifestyle intervention, body fat distribution, prevention
- Medical subject headings
- Diabetes Mellitus, Type 2, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intensified lifestyle interventionBehavioural
- physical activity 6 hours per week, 50% guided activity
- recorded by an accelerometer (Aipermotion 440)
- 16 sessions per year with a lifestyle advisor
- nutritional advice (target weight: 5% less, if BMI > 25kg/m², less than 30% fat per caloric intake, less than 10% fatty acids per caloric intake, more than 15 g fibre per 1000 kcl)
normal lifestyle interventionBehavioural
- physical activity 3 hours per week
- recorded by an accelerometer (Aipermotion 440)
- 8 sessions per year with a lifestyle advisor
- nutritional advice (target weight: 5% less, if BMI > 25kg/m², less than 30% fat per caloric intake, less than 10% fatty acids per caloric intake, more than 15 g fibre per 1000 kcl)
Single lifestyle adviceBehavioural
- Single Health care advice and lifestyle advice (30 minutes) at the beginning
- recommend the individual target weight (5% less, if BMI 25> kg/m²)
| Study group | Role | What they receive |
|---|---|---|
| high risk non-responder, intensified lifestyle intervention | Active comparator | high risk non-responder:
* A) reduced Insulin secretion (disposition index: (IGI * ISI-Matsuda)< 760)
* B) insulin resistance (ISI-Matsuda < 9,2)
* C) elevated liver fat ( MRT > 5,56%)
* A+B or A+C or B+C or A+B+C Receives: Behavioral: intensified lifestyle intervention |
| hight risk non responder, normal lifestyle intervention | Active comparator | high risk non-responder:
* A) reduced Insulin secretion (disposition index: (IGI * ISI-Matsuda)< 760)
* B) insulin resistance (ISI-Matsuda < 9,2)
* C) elevated liver fat ( MRT > 5,56%)
* A+B or A+C or B+C or A+B+C Receives: Behavioral: normal lifestyle intervention |
| Responder, normal lifestyle intervention | Active comparator | Responder:
* A) reduced Insulin secretion (disposition index: (IGI * ISI-Matsuda)< 760)
* B) insulin resistance (ISI-Matsuda < 9,2)
* C) elevated liver fat ( MRT > 5,56%)
* No A, only B or C Receives: Behavioral: normal lifestyle intervention |
| Responder, single lifestyle advice (control group) | Active comparator | Responder:
* A) reduced Insulin secretion (disposition index: (IGI * ISI-Matsuda)< 760)
* B) insulin resistance (ISI-Matsuda < 9,2)
* C) elevated liver fat ( MRT > 5,56%)
* No A, only B or C Receives: Behavioral: Single lifestyle advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
postprandial glycaemia (2h plasma glucose level of the 75 g oral glucose tolerance test (OGTT))
Measured: one year
Secondary outcomes (3)
insulin sensitivity confirmed by 75 g oral glucose tolerance test (OGTT)
insulin resistance is calculated as follows:
- Insulinogenic index (IGI) = (I30 - I0) / (G30 - G0)
- ISIest= 10000/²√ ((G0 x I0) x ((G0+G30+G60+G90+G120)/5) x ((I0+I30+I60+I90+I120)/5))
Measured: one year
insulin secretion confirmed by 75 g oral glucose tolerance test (OGTT)
insulin resistance is calculated as follows:
- Insulinogenic index (IGI) = (I30 - I0) / (G30 - G0)
- ISIest= 10000/²√ ((G0 x I0) x ((G0+G30+G60+G90+G120)/5) x ((I0+I30+I60+I90+I120)/5))
Measured: one year
distribution of body fat confirmed by MR-Imaging and proton magnetic resonance spectroscopy by 3 T whole body imager
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startMar 2012
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,145 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- German Diabetes-Center, Leibniz-Institut in Düsseldorf, Endocrinology and Metabolic Diseases, Charité Berlin, German Institute of Human Nutrition, University Hospital Carl Gustav Carus, LMU Klinikum, University Hospital Heidelberg
- Responsible party
- Principal investigator, andreas fritsche, University Hospital Tuebingen
- Investigators
- Andreas Fritsche, Prof. Dr. med, Principal investigator, University Hospital TuebingenNorbert Stefan, Prof.Dr.med., Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947595
- Sponsor's protocol ID
- DZD-2012
- Acronym
- PLIS
- Status last verified
- Aug 2017
- First submitted
- 25 Jun 2013
- Last updated
- 23 Aug 2017
- Results posted
- No
Publications
Wagner R, Eckstein SS, Fritsche L, Prystupa K, Horber S, Haring HU, Birkenfeld AL, Peter A, Fritsche A, Heni M. Postprandial Dynamics of Proglucagon Cleavage Products and Their Relation to Metabolic Health. Front Endocrinol (Lausanne). 2022 Jun 29;13:892677. doi: 10.3389/fendo.2022.892677. eCollection 2022.
PubMed 35872982Fritsche A, Wagner R, Heni M, Kantartzis K, Machann J, Schick F, Lehmann R, Peter A, Dannecker C, Fritsche L, Valenta V, Schick R, Nawroth PP, Kopf S, Pfeiffer AFH, Kabisch S, Dambeck U, Stumvoll M, Bluher M, Birkenfeld AL, Schwarz P, Hauner H, Clavel J, Seissler J, Lechner A, Mussig K, Weber K, Laxy M, Bornstein S, Schurmann A, Roden M, de Angelis MH, Stefan N, Haring HU. Different Effects of Lifestyle Intervention in High- and Low-Risk Prediabetes: Results of the Randomized Controlled Prediabetes Lifestyle Intervention Study (PLIS). Diabetes. 2021 Dec;70(12):2785-2795. doi: 10.2337/db21-0526. Epub 2021 Sep 16.
PubMed 34531293
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediabetes Lifestyle Intervention Study
- ClinicalTrials.gov ID
- NCT01947595
- Acronym / sponsor ID
- PLIS / DZD-2012
- Conditions
- Diabetes Mellitus Type 2
- Keywords
- diabetes mellitus type 2, impaired glucose tolerance, lifestyle intervention, body fat distribution, prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,145 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- German Diabetes-Center, Leibniz-Institut in Düsseldorf, Endocrinology and Metabolic Diseases, Charité Berlin, German Institute of Human Nutrition, University Hospital Carl Gustav Carus, LMU Klinikum, University Hospital Heidelberg
- Study start
- Mar 2012
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 20 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this prospective randomized multicenter intervention study is to determine whether in the prevention of Diabetes an intensified lifestyle intervention is superior to a conventional lifestyle intervention in high risk non-Responder subjects. Further, the intensive phenotyping to determine subgroups with an increased risk for diabetes enables an individualized prevention and therapy of type 2 diabetes mellitus.
Detailed description
The study start with an intensive phenotyping at baseline (initial examination) to determine subjects with prediabetes. These high risk non-Responder are randomized in two arms (intensified vs normal lifestyle intervention)with equal number of subjects (n=250). The results are compared with each other at the end of the study.
The low risk Responder are randomized in two arms (normal vs. once lifestyle intervention = control group) with equal number of subjects (n=250).
After the screening at baseline the 12 month lifestyle intervention starts for lifestyle intervention groups. The different therapy groups are formed as described before. The subjects with intensified lifestyle intervention get 16 consultations, the subjects with normal lifestyle intervention get 8 consultations, the subjects of the control group get one consultation to learn more about a healthier lifestyle. During the whole study there is a continuous supervision from physician and nutritional advisers and the subjects have to document a nutrition and an exercise protocol as well as subjective measurements. At baseline, after 24 weeks and at follow up 1, 2 and 3 years later there is an elaborate metabolic characterization of all subjects (also the Responder groups) a 75 g venous oral glucose tolerance test (OGTT) as well as an analysis of the distribution of body fat confirmed by MR-Imaging and proton magnetic resonance spectroscopy by 3 T whole body imager.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| high risk non-responder, intensified lifestyle intervention | Active comparator | Behavioral: intensified lifestyle interventionhigh risk non-responder: * A) reduced Insulin secretion (disposition index: (IGI * ISI-Matsuda)< 760) * B) insulin resistance (ISI-Matsuda < 9,2) * C) elevated liver fat ( MRT > 5,56%) * A+B or A+C or B+C or A+B+C |
| hight risk non responder, normal lifestyle intervention | Active comparator | Behavioral: normal lifestyle interventionhigh risk non-responder: * A) reduced Insulin secretion (disposition index: (IGI * ISI-Matsuda)< 760) * B) insulin resistance (ISI-Matsuda < 9,2) * C) elevated liver fat ( MRT > 5,56%) * A+B or A+C or B+C or A+B+C |
| Responder, normal lifestyle intervention | Active comparator | Behavioral: normal lifestyle interventionResponder: * A) reduced Insulin secretion (disposition index: (IGI * ISI-Matsuda)< 760) * B) insulin resistance (ISI-Matsuda < 9,2) * C) elevated liver fat ( MRT > 5,56%) * No A, only B or C |
| Responder, single lifestyle advice (control group) | Active comparator | Behavioral: Single lifestyle adviceResponder: * A) reduced Insulin secretion (disposition index: (IGI * ISI-Matsuda)< 760) * B) insulin resistance (ISI-Matsuda < 9,2) * C) elevated liver fat ( MRT > 5,56%) * No A, only B or C |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- impaired fasting glucose (IFG)
- and/or
- impaired glucose tolerance (IGT)
Key exclusion criteria (36 listed)
- current pregnancy or breastfeeding
- BMI > 45 kg/m²
- Diabetes mellitus Typ 1 or 2
- serious disease e.g symptomatic coronary heart disease
- serious symptomatic malignant disease (weight loss > 10% within the last 6 month)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intensified lifestyle intervention* physical activity 6 hours per week, 50% guided activity * recorded by an accelerometer (Aipermotion 440) * 16 sessions per year with a lifestyle advisor * nutritional advice (target weight: 5% less, if BMI > 25kg/m², less than 30% fat per caloric intake, less than 10% fatty acids per caloric intake, more than 15 g fibre per 1000 kcl) | Behavioural | high risk non-responder, intensified lifestyle intervention |
| normal lifestyle intervention* physical activity 3 hours per week * recorded by an accelerometer (Aipermotion 440) * 8 sessions per year with a lifestyle advisor * nutritional advice (target weight: 5% less, if BMI > 25kg/m², less than 30% fat per caloric intake, less than 10% fatty acids per caloric intake, more than 15 g fibre per 1000 kcl) | Behavioural | Responder, normal lifestyle intervention, hight risk non responder, normal lifestyle intervention |
| Single lifestyle advice- Single Health care advice and lifestyle advice (30 minutes) at the beginning * recommend the individual target weight (5% less, if BMI 25> kg/m²) | Behavioural | Responder, single lifestyle advice (control group) |
Primary outcome
postprandial glycaemia (2h plasma glucose level of the 75 g oral glucose tolerance test (OGTT))
Time frame: one year
3 secondary outcomes
insulin sensitivity confirmed by 75 g oral glucose tolerance test (OGTT)
Time frame: one year
insulin secretion confirmed by 75 g oral glucose tolerance test (OGTT)
Time frame: one year
distribution of body fat confirmed by MR-Imaging and proton magnetic resonance spectroscopy by 3 T whole body imager
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2017.
- Derived from this study: PubMed 35872982Wagner R, Eckstein SS, Fritsche L, Prystupa K, Horber S, Haring HU, Birkenfeld AL, Peter A, Fritsche A, Heni M. Postprandial Dynamics of Proglucagon Cleavage Products and Their Relation to Metabolic Health. Front Endocrinol (Lausanne). 2022 Jun 29;13:892677. doi: 10.3389/fendo.2022.892677. eCollection 2022.
- Derived from this study: PubMed 34531293Fritsche A, Wagner R, Heni M, Kantartzis K, Machann J, Schick F, Lehmann R, Peter A, Dannecker C, Fritsche L, Valenta V, Schick R, Nawroth PP, Kopf S, Pfeiffer AFH, Kabisch S, Dambeck U, Stumvoll M, Bluher M, Birkenfeld AL, Schwarz P, Hauner H, Clavel J, Seissler J, Lechner A, Mussig K, Weber K, Laxy M, Bornstein S, Schurmann A, Roden M, de Angelis MH, Stefan N, Haring HU. Different Effects of Lifestyle Intervention in High- and Low-Risk Prediabetes: Results of the Randomized Controlled Prediabetes Lifestyle Intervention Study (PLIS). Diabetes. 2021 Dec;70(12):2785-2795. doi: 10.2337/db21-0526. Epub 2021 Sep 16.
- Click here for more information about this study: research in the DZD --\> klinische StudienLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Fritsche, Prof. Dr. med principal investigator
University Hospital Tuebingen
Norbert Stefan, Prof.Dr.med. principal investigator
University Hospital Tuebingen
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intensified lifestyle intervention, normal lifestyle intervention and Single lifestyle advice in people with Diabetes Mellitus Type 2, run by University Hospital Tuebingen at 7 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postprandial glycaemia (2h plasma glucose level of the 75 g oral glucose tolerance test (OGTT)) (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01947595, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2017.