Phase 4 N=182 Randomized Prevention

Evaluation of a Primary Type 2 Diabetes Prevention Programme

Diabetes Mellitus

Bottom Line

View on ClinicalTrials.gov: NCT00707447 ↗

Enrolled (actual)

182

Serious AEs

0.0%

Results posted

Aug 2014

Primary outcome: Primary: Weight Change — -3.8; -1.4 kg — p=<.05

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: PREDIAS (Behavioral); Control (Behavioral)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Forschungsinstitut der Diabetes Akademie Mergentheim
Primary completion: Dec 2005

Outcome Measures

Outcome	Result	p-value
PRIMARY Weight Change	-3.8; -1.4	<.05 sig
PRIMARY Waist Circumference	-4.1; -0.4	<.05 sig
SECONDARY Fasting Glucose	-4.3; 1.8	<.05 sig
SECONDARY Glucose Tolerance	-7.3; -8.2	<.05 sig
SECONDARY Physical Exercise	46.6; 17.9	<.05 sig
SECONDARY Eating Behavior (TFEQ) - Cognitive Restraint	3.9; 1.5	<.05 sig
SECONDARY Eating Behavior (TFEQ) - Disinhibition	-1.2; -0.4	<.05 sig
SECONDARY Eating Behavior (TFEQ) - Hunger	-1.1; -0.2	<.05 sig
SECONDARY Psychological Well-being (WHO-5)	1.4; 0.0	<.05 sig
SECONDARY Emotional Well-being/ Depression (CES-D)	-3.5; -1.0	<.05 sig

Summary

A type 2 diabetes prevention programme, named PREDIAS was developed. It consists of 12 lessons delivered as group sessions. Die efficacy of PREDIAS was studied in a randomized controlled study with 12 month follow up. Control group received written information about diabetes risk. Primary outcome variable was weight reduction at 12 months follow up. Secondary variables were impact of the intervention on glycemic parameters, lipids, eating and exercise behavior and other metabolic risk factors

Eligibility Criteria

Inclusion Criteria

impaired fasting glucose and/or
impaired glucose tolerance
overweight (BMI > 26 kg/m²)

Exclusion Criteria

type 2 diabetes
severe illness (cancer diagnosis, stroke or myocardial infarction in the last 12 months)
diagnosis of a current mental disease

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00707447). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.