Individualized Lifestyle Intervention in Subjects With Prediabetes

NCT ID: NCT01947595

Last Updated: 2017-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1145 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2017-08-31

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.

Conditions

Diabetes Mellitus Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

intensified lifestyle intervention

Intervention Type: BEHAVIORAL

• 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)

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

Group Type: ACTIVE_COMPARATOR

normal lifestyle intervention

Intervention Type: BEHAVIORAL

• 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)

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

Group Type: ACTIVE_COMPARATOR

normal lifestyle intervention

Intervention Type: BEHAVIORAL

• 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)

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

Group Type: ACTIVE_COMPARATOR

Single lifestyle advice

Intervention Type: BEHAVIORAL

• Single Health care advice and lifestyle advice (30 minutes) at the beginning

• recommend the individual target weight (5% less, if BMI 25> kg/m²)

Interventions

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)

Intervention Type: 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)

Intervention Type: 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)

Intervention Type: BEHAVIORAL

Eligibility 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Diabetes-Center, Leibniz-Institut in Düsseldorf

OTHER

Sponsor Role: collaborator

Endocrinology and Metabolic Diseases, Charité Berlin

UNKNOWN

Sponsor Role: collaborator

German Institute of Human Nutrition

OTHER

Sponsor Role: collaborator

University Hospital Carl Gustav Carus

OTHER

Sponsor Role: collaborator

LMU München, medical clinic IV

UNKNOWN

Sponsor Role: collaborator

University Hospital Heidelberg

OTHER

Sponsor Role: collaborator

University Hospital Tuebingen

OTHER

Sponsor Role: lead

Responsible Party

andreas fritsche

Prof. Dr. med. Andreas Fritsche

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andreas Fritsche, Prof. Dr. med

Role: PRINCIPAL_INVESTIGATOR

University Hospital Tuebingen

Norbert Stefan, Prof.Dr.med.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Tübingen

Locations

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

Helmholtz Zentrum München

Munich, , Germany

Ludwig-Maximilians-University

Munich, , Germany

University Hospital Tübingen

Tübingen, , Germany

Countries

Germany

References

Wagner R, Eckstein SS, Fritsche L, Prystupa K, Horber S, Haring HU, Birkenfeld AL, Peter A, Fritsche A, Heni M. Postprandial Dynamics of Proglucagon Cleavage Products and Their Relation to Metabolic Health. Front Endocrinol (Lausanne). 2022 Jun 29;13:892677. doi: 10.3389/fendo.2022.892677. eCollection 2022.

Reference Type: DERIVED

PMID: 35872982 (View on PubMed)

Fritsche A, Wagner R, Heni M, Kantartzis K, Machann J, Schick F, Lehmann R, Peter A, Dannecker C, Fritsche L, Valenta V, Schick R, Nawroth PP, Kopf S, Pfeiffer AFH, Kabisch S, Dambeck U, Stumvoll M, Bluher M, Birkenfeld AL, Schwarz P, Hauner H, Clavel J, Seissler J, Lechner A, Mussig K, Weber K, Laxy M, Bornstein S, Schurmann A, Roden M, de Angelis MH, Stefan N, Haring HU. Different Effects of Lifestyle Intervention in High- and Low-Risk Prediabetes: Results of the Randomized Controlled Prediabetes Lifestyle Intervention Study (PLIS). Diabetes. 2021 Dec;70(12):2785-2795. doi: 10.2337/db21-0526. Epub 2021 Sep 16.

Reference Type: DERIVED

PMID: 34531293 (View on PubMed)

Related Links

http://www.dzd-ev.de

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

Other Identifiers

DZD-2012

Identifier Type: -

Identifier Source: org_study_id