Individualized Lifestyle Intervention in Subjects With Prediabetes
PLIS
Prediabetes Lifestyle Intervention Study
1 other identifier
interventional
1,145
1 country
7
Brief 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. Further, the intensive phenotyping to determine subgroups with an increased risk for diabetes enables an individualized prevention and therapy of type 2 diabetes mellitus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started Mar 2012
Longer than P75 for not_applicable diabetes-mellitus-type-2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 25, 2013
CompletedFirst Posted
Study publicly available on registry
September 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedAugust 23, 2017
August 1, 2017
5.4 years
June 25, 2013
August 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
postprandial glycaemia (2h plasma glucose level of the 75 g oral glucose tolerance test (OGTT))
one year
Secondary Outcomes (3)
insulin sensitivity confirmed by 75 g oral glucose tolerance test (OGTT)
one year
insulin secretion confirmed by 75 g oral glucose tolerance test (OGTT)
one year
distribution of body fat confirmed by MR-Imaging and proton magnetic resonance spectroscopy by 3 T whole body imager
one year
Other Outcomes (2)
metabolic and genetic characterization to determine the risk of type 2 diabetes confirmed by case history, clinical examination, venous blood sampling, DNA isolation, standardised questionnaires, bio-electric impedance analysis (BIA)and ergospirometry
one year
metabolic and genetic characterization to determine the non-response to lifestyle intervention confirmed by case history, clinical examination, venous blood sampling, DNA isolation, standardised questionnaires,BIA, ergospirometry
one year
Study Arms (4)
high risk non-responder, intensified lifestyle intervention
ACTIVE COMPARATORhigh 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 COMPARATORhigh 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 COMPARATORResponder: * 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 COMPARATORResponder: * 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
Interventions
* 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)
* 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 Health care advice and lifestyle advice (30 minutes) at the beginning * recommend the individual target weight (5% less, if BMI 25\> kg/m²)
Eligibility Criteria
You may qualify if:
- impaired fasting glucose (IFG)
- fasting blood glucose 99-126 mg/dl
- and/or
- impaired glucose tolerance (IGT)
- g OGTT 120 minutes: 139-200 mg/dl
You may not qualify if:
- 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)
- 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
- +21 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital Tuebingenlead
- German Diabetes-Center, Leibniz-Institut in Düsseldorfcollaborator
- Endocrinology and Metabolic Diseases, Charité Berlincollaborator
- German Institute of Human Nutritioncollaborator
- University Hospital Carl Gustav Caruscollaborator
- LMU München, medical clinic IVcollaborator
- University Hospital Heidelbergcollaborator
Study Sites (7)
Deutsches Institut für Ernährungsforschung / Charité Berlin
Berlin, Germany
University Hospital Dresden
Dresden, Germany
Deutsches Diabetes Zentrum
Düsseldorf, 40225, Germany
Technische Universität München (TU Munich)
Munich, 80333, Germany
Helmholtz Zentrum München
Munich, 85764, Germany
Ludwig-Maximilians-University
Munich, Germany
University Hospital Tübingen
Tübingen, 72076, Germany
Related Publications (2)
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.
PMID: 35872982DERIVEDFritsche 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.
PMID: 34531293DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andreas Fritsche, Prof. Dr. med
University Hospital Tuebingen
- PRINCIPAL INVESTIGATOR
Norbert Stefan, Prof.Dr.med.
University Hospital Tübingen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. med. Andreas Fritsche
Study Record Dates
First Submitted
June 25, 2013
First Posted
September 20, 2013
Study Start
March 1, 2012
Primary Completion
August 1, 2017
Study Completion
August 1, 2017
Last Updated
August 23, 2017
Record last verified: 2017-08