Individualized Lifestyle Intervention in Subjects With Prediabetes

Diabetes Mellitus Type 2 Clinical Trial

— PLIS  

Official title:

Prediabetes Lifestyle Intervention Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01947595
• Other study ID #: DZD-2012
• Status: Completed
• Phase: N/A
• First received: June 25, 2013
• Last updated: August 22, 2017
• Start date: March 2012
• Est. completion date: August 2017

Study information

• Verified date: August 2017
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1145
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2
• Glucose Intolerance
• Prediabetic State

Intervention

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)
• 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)
• 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)

Locations

Country	Name	City	State
Germany	Deutsches Institut für Ernährungsforschung / Charité Berlin	Berlin
Germany	University Hospital Dresden	Dresden
Germany	Deutsches Diabetes Zentrum	Düsseldorf
Germany	Helmholtz Zentrum München	Munich
Germany	Ludwig-Maximilians-University	Munich
Germany	Technische Universität München (TU Munich)	Munich
Germany	University Hospital Tübingen	Tübingen

Sponsors (7)

Lead Sponsor	Collaborator
University Hospital Tuebingen	Endocrinology and Metabolic Diseases, Charité Berlin, German Diabetes-Center, Leibniz-Institut in Düsseldorf, German Institute of Human Nutrition, LMU München, medical clinic IV, University Hospital Carl Gustav Carus, University Hospital Heidelberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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		one year
Other	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		one year
Primary	postprandial glycaemia (2h plasma glucose level of the 75 g oral glucose tolerance test (OGTT))		one year
Secondary	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= 10000/²v ((G0 x I0) x ((G0+G30+G60+G90+G120)/5) x ((I0+I30+I60+I90+I120)/5))	one year
Secondary	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= 10000/²v ((G0 x I0) x ((G0+G30+G60+G90+G120)/5) x ((I0+I30+I60+I90+I120)/5))	one year
Secondary	distribution of body fat confirmed by MR-Imaging and proton magnetic resonance spectroscopy by 3 T whole body imager		one year

External Links

•   Click here for more information about this study: research in the DZD --> klinische Studien