Individualized Lifestyle Intervention in Subjects With Prediabetes (PLIS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University Hospital Tuebingen
Sponsor:
Collaborators:
German Diabetes-Center, Leibniz-Institutt in Düsseldorf
Department of Endocrinology and Metabolic Diseases, Charité Berlin
German Institute of Human Nutrition (DIfE)
Department of the medical clinic III University Hospital Carl Gustav Carus Dresden
LMU München, medical clinic IV
Department of Endocrinology and Metabolism at Heidelberg University Hospital
Information provided by (Responsible Party):
andreas fritsche, University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT01947595
First received: June 25, 2013
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Diabetes Mellitus Type 2
Behavioral: intensified lifestyle intervention
Behavioral: normal lifestyle intervention
Behavioral: Single lifestyle advice

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prediabetes Lifestyle Intervention Study

Resource links provided by NLM:


Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • postprandial glycaemia (2h plasma glucose level of the 75 g oral glucose tolerance test (OGTT)) [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • insulin sensitivity confirmed by 75 g oral glucose tolerance test (OGTT) [ Time Frame: one year ] [ Designated as safety issue: No ]

    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) [ Time Frame: one year ] [ Designated as safety issue: No ]

    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 [ Time Frame: one year ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: March 2012
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: high risk non-responder, intensified lifestyle intervention

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
Behavioral: 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)
Active Comparator: hight risk non responder, normal lifestyle intervention

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
Behavioral: 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)
Active Comparator: Responder, normal lifestyle intervention

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
Behavioral: 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)
Active Comparator: Responder, single lifestyle advice (control group)

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
Behavioral: 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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01947595

Contacts
Contact: Andreas Fritsche, Prof.Dr.med 00497071/29-5974 Andreas.fritsche@med.uni-tuebingen.de

Locations
Germany
Deutsches Institut für Ernährungsforschung / Charité Berlin Recruiting
Berlin, Germany
Contact: Andreas Pfeiffer, Prof.    004933200-882778    gesund.leben@dife.de   
Contact    004933200-882774      
Principal Investigator: Andreas Pfeiffer, Prof.         
University Hospital Dresden Recruiting
Dresden, Germany
Contact: Peter Schwarz, Prof.    0049351-4582715    peter.schwarz@uniklinikum-dresden.de   
Principal Investigator: Peter Schwarz, Prof.         
Deutsches Diabetes Zentrum Recruiting
Düsseldorf, Germany, 40225
Contact: Karsten Müssig, Prof.    0049211-3382209    studienzentrum@ddz.uni-duesseldorf.de   
Principal Investigator: Karsten Müssig, Prof.         
Principal Investigator: Bettina Nowotny, Dr.         
Helmholtz Zentrum München Recruiting
Munich, Germany, 85764
Contact: Anette-Gabriele Ziegler, Prof. Dr.    004989/31874790    prevent.diabetes@lrz.uni-muenchen.de   
Principal Investigator: Anette-Gabriele Ziegler, Prof.Dr.med.         
Ludwig-Maximilians-University Recruiting
Munich, Germany
Contact: Jochen Seissler, Prof.    004989-5160-2288    studienzentrum-diabetes@med.uni-muenchen.de   
Principal Investigator: Jochen Seißler, Prof.         
Principal Investigator: Andreas Lechner, Dr.         
Technische Universität München (TU Munich) Recruiting
Munich, Germany, 80333
Contact: Hans Hauner, Prof.    004989-289 249 -16    julia.stoll@tum.de   
Contact    004986-289249-25    julia.petzold@tum.de   
Principal Investigator: Hans Hauner, Prof.         
University Hospital Tübingen Recruiting
Tübingen, Germany, 72076
Contact: Andreas Fritsche, Prof.Dr.med    00497071/29-80590    Andreas.fritsche@med.uni-tuebingen.de   
Principal Investigator: Andreas Fritsche, Prof.Dr.med.         
Principal Investigator: Norbert Stefan, Prof.Dr.med.         
Sponsors and Collaborators
University Hospital Tuebingen
German Diabetes-Center, Leibniz-Institutt in Düsseldorf
Department of Endocrinology and Metabolic Diseases, Charité Berlin
German Institute of Human Nutrition (DIfE)
Department of the medical clinic III University Hospital Carl Gustav Carus Dresden
LMU München, medical clinic IV
Department of Endocrinology and Metabolism at Heidelberg University Hospital
Investigators
Principal Investigator: Andreas Fritsche, Prof. Dr. med University Hospital Tuebingen
Principal Investigator: Norbert Stefan, Prof.Dr.med. University Hospital Tübingen
  More Information

Additional Information:
No publications provided

Responsible Party: andreas fritsche, Prof. Dr. med. Andreas Fritsche, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT01947595     History of Changes
Other Study ID Numbers: DZD-2012
Study First Received: June 25, 2013
Last Updated: September 17, 2013
Health Authority: Germany: Federal Ministry of Education and Research

Keywords provided by University Hospital Tuebingen:
diabetes mellitus type 2
impaired glucose tolerance
lifestyle intervention
body fat distribution

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 18, 2014