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Individualized Lifestyle Intervention in Subjects With Prediabetes (PLIS)

Primary Purpose

Diabetes Mellitus Type 2

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
intensified lifestyle intervention
normal lifestyle intervention
Single lifestyle advice
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus Type 2 focused on measuring diabetes mellitus type 2, impaired glucose tolerance, lifestyle intervention, body fat distribution, prevention

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

  • exclusion criteria for magnetic resonance tomography

    • 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

Sites / Locations

  • Deutsches Institut für Ernährungsforschung / Charité Berlin
  • University Hospital Dresden
  • Deutsches Diabetes Zentrum
  • Technische Universität München (TU Munich)
  • Helmholtz Zentrum München
  • Ludwig-Maximilians-University
  • University Hospital Tübingen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

high risk non-responder, intensified lifestyle intervention

hight risk non responder, normal lifestyle intervention

Responder, normal lifestyle intervention

Responder, single lifestyle advice (control group)

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

postprandial glycaemia (2h plasma glucose level of the 75 g oral glucose tolerance test (OGTT))

Secondary Outcome Measures

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))
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))
distribution of body fat confirmed by MR-Imaging and proton magnetic resonance spectroscopy by 3 T whole body imager

Full Information

First Posted
June 25, 2013
Last Updated
August 22, 2017
Sponsor
University Hospital Tuebingen
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 München, medical clinic IV, University Hospital Heidelberg
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1. Study Identification

Unique Protocol Identification Number
NCT01947595
Brief Title
Individualized Lifestyle Intervention in Subjects With Prediabetes
Acronym
PLIS
Official Title
Prediabetes Lifestyle Intervention Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Tuebingen
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 München, medical clinic IV, University Hospital Heidelberg

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2
Keywords
diabetes mellitus type 2, impaired glucose tolerance, lifestyle intervention, body fat distribution, prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
high risk non-responder, intensified lifestyle intervention
Arm Type
Active Comparator
Arm Description
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
Arm Title
hight risk non responder, normal lifestyle intervention
Arm Type
Active Comparator
Arm Description
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
Arm Title
Responder, normal lifestyle intervention
Arm Type
Active Comparator
Arm Description
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
Arm Title
Responder, single lifestyle advice (control group)
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
intensified lifestyle intervention
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
normal lifestyle intervention
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Single lifestyle advice
Intervention Description
- Single Health care advice and lifestyle advice (30 minutes) at the beginning recommend the individual target weight (5% less, if BMI 25> kg/m²)
Primary Outcome Measure Information:
Title
postprandial glycaemia (2h plasma glucose level of the 75 g oral glucose tolerance test (OGTT))
Time Frame
one year
Secondary Outcome Measure Information:
Title
insulin sensitivity confirmed by 75 g oral glucose tolerance test (OGTT)
Description
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))
Time Frame
one year
Title
insulin secretion confirmed by 75 g oral glucose tolerance test (OGTT)
Description
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))
Time Frame
one year
Title
distribution of body fat confirmed by MR-Imaging and proton magnetic resonance spectroscopy by 3 T whole body imager
Time Frame
one year
Other Pre-specified Outcome Measures:
Title
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
Time Frame
one year
Title
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
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 exclusion criteria for magnetic resonance tomography 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Fritsche, Prof. Dr. med
Organizational Affiliation
University Hospital Tuebingen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Norbert Stefan, Prof.Dr.med.
Organizational Affiliation
University Hospital Tübingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Deutsches Institut für Ernährungsforschung / Charité Berlin
City
Berlin
Country
Germany
Facility Name
University Hospital Dresden
City
Dresden
Country
Germany
Facility Name
Deutsches Diabetes Zentrum
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Technische Universität München (TU Munich)
City
Munich
ZIP/Postal Code
80333
Country
Germany
Facility Name
Helmholtz Zentrum München
City
Munich
ZIP/Postal Code
85764
Country
Germany
Facility Name
Ludwig-Maximilians-University
City
Munich
Country
Germany
Facility Name
University Hospital Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
35872982
Citation
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.
Results Reference
derived
PubMed Identifier
34531293
Citation
Fritsche 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.
Results Reference
derived
Links:
URL
http://www.dzd-ev.de
Description
Click here for more information about this study: research in the DZD --> klinische Studien

Learn more about this trial

Individualized Lifestyle Intervention in Subjects With Prediabetes

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