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

June 25, 2013
September 17, 2013
March 2012
March 2015   (final data collection date for primary outcome measure)
postprandial glycaemia (2h plasma glucose level of the 75 g oral glucose tolerance test (OGTT)) [ Time Frame: one year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01947595 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
  • 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 ]
Same as current
 
Individualized Lifestyle Intervention in Subjects With Prediabetes
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Diabetes Mellitus Type 2
  • 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)
  • 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)
  • 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)
  • 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
    Intervention: Behavioral: intensified lifestyle intervention
  • 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
    Intervention: Behavioral: normal lifestyle intervention
  • 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
    Intervention: Behavioral: normal lifestyle intervention
  • 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
    Intervention: Behavioral: Single lifestyle advice
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
Not Provided
March 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Andreas Fritsche, Prof.Dr.med 00497071/29-5974 Andreas.fritsche@med.uni-tuebingen.de
Germany
 
NCT01947595
DZD-2012
Not Provided
andreas fritsche, University Hospital Tuebingen
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
Principal Investigator: Andreas Fritsche, Prof. Dr. med University Hospital Tuebingen
Principal Investigator: Norbert Stefan, Prof.Dr.med. University Hospital Tübingen
University Hospital Tuebingen
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP