Prediabetes Lifestyle Intervention Study

Status: Completed
Location: See all (7) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: No
View:

• 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

Locations
Other Locations
Germany
Deutsches Institut für Ernährungsforschung / Charité Berlin
Berlin
University Hospital Dresden
Dresden
Deutsches Diabetes Zentrum
Düsseldorf
Helmholtz Zentrum München
Munich
Ludwig-Maximilians-University
Munich
Technische Universität München (TU Munich)
Munich
University Hospital Tübingen
Tübingen
Time Frame
Start Date: March 2012
Completion Date: August 2017
Participants
Target number of participants: 1145
Treatments
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
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
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
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
Sponsors
Collaborators: German Institute of Human Nutrition, Endocrinology and Metabolic Diseases, Charité Berlin, LMU München, medical clinic IV, University Hospital Heidelberg, German Diabetes-Center, Leibniz-Institut in Düsseldorf, University Hospital Carl Gustav Carus
Leads: University Hospital Tuebingen

This content was sourced from clinicaltrials.gov

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