Individualized Lifestyle Intervention in Subjects With Prediabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus Type 2
• Interventions: Behavioral: normal lifestyle intervention; Behavioral: intensified lifestyle intervention; Behavioral: Single lifestyle advice

• Registration Number: NCT01947595
• Lead Sponsor: University Hospital Tuebingen

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.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2013-06-25
• Study First Submitted QC: 2013-09-17
• Study First Posted: 2013-09-20
• Status Verified: 2017-08
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Last Update Submitted: 2017-08-22
• Last Update Posted: 2017-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1145

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hight risk non responder, normal lifestyle intervention	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
Responder, normal lifestyle intervention	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
high risk non-responder, intensified lifestyle intervention	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
Responder, single lifestyle advice (control group)	Single lifestyle advice	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

Primary Outcome Measures

Name	Time	Method
postprandial glycaemia (2h plasma glucose level of the 75 g oral glucose tolerance test (OGTT))	one year

Secondary Outcome Measures

Name	Time	Method
distribution of body fat confirmed by MR-Imaging and proton magnetic resonance spectroscopy by 3 T whole body imager	one year
insulin sensitivity confirmed by 75 g oral glucose tolerance test (OGTT)	one year	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)	one year	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))

Trial Locations

Locations (7)

Deutsches Institut für Ernährungsforschung / Charité Berlin; 🇩🇪 Berlin, Germany

University Hospital Dresden; 🇩🇪 Dresden, Germany

Technische Universität München (TU Munich); 🇩🇪 Munich, Germany

Deutsches Diabetes Zentrum; 🇩🇪 Düsseldorf, Germany

Helmholtz Zentrum München; 🇩🇪 Munich, Germany

Ludwig-Maximilians-University; 🇩🇪 Munich, Germany

University Hospital Tübingen; 🇩🇪 Tübingen, Germany