Individualized Lifestyle Intervention in Subjects With Prediabetes

N/ACompletedNCT01947595

University Hospital Tuebingen1,145 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

1,145

Conditions

Diabetes Mellitus Type 2

Interventions

intensified lifestyle interventionBEHAVIORAL

* 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)

normal lifestyle interventionBEHAVIORAL

* 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 lifestyle adviceBEHAVIORAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (7)

Deutsches Institut für Ernährungsforschung / Charité Berlin

Berlin, Germany

University Hospital Dresden

Dresden, Germany

Deutsches Diabetes Zentrum

Düsseldorf, Germany

Technische Universität München (TU Munich)

Munich, Germany

Outcomes

Primary Outcomes

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

Time frame: one year

Secondary Outcomes

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))

Time frame: one year

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))

Time frame: one year

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

Time frame: one year

Data from ClinicalTrials.gov

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