PROSPERO International prospective register of systematic reviews
Gender-related differences in diabetes prevention
Anna Glechner, Juergen Harreiter, Sonja Rohleder, Alexander Kautzky, Megan Grace Van Noord, Angela Kaminski - Hartenthaler, Gerald Gartlehner, Jaako Tuomilehto, Alexandra Kautzky - Willer
Anna Glechner, Juergen Harreiter, Sonja Rohleder, Alexander Kautzky, Megan Grace Van Noord, Angela Kaminski - Hartenthaler, Gerald Gartlehner, Jaako Tuomilehto, Alexandra Kautzky - Willer. Gender-related differences in diabetes prevention.
Available from http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42012003102
Are there any sex specific differences in the general efficacy and safety of oral antidiabetic therapies (versus placebo, observation, no intervention) to avoid manifestation of diabetes in a population with prediabetes?
Are there any sex specific differences in the general efficacy and safety of lifestyle interventions (observation, no intervention) to avoid a manifestation of diabetes in a population with prediabetes?
Are there any sex specific differences in the relative efficacy and safety of oral antidiabetic therapies versus lifestyle-interventions to avoid a manifestation of diabetes in a population with prediabetes?
Various electronic databases: PubMed, EMBASE, Cochrane Library
Grey literature (grey matters, open grey)
Unpublished data from manufacturers, if available
Search date: 1980-2012
Languages: English, German
Manual search: semi-automated with Scopus
Dual review of the literature
Types of study to be included
To assess the comparative benefit, randomised controlled studies (RCTs) or systematic reviews and meta-analyses of RCTs will be taken into account. The minimum study duration is one year.
To assess side effects, additionally controlled, prospective cohort studies with low or unclear bias risk will be included (minimum study size n=500, study duration minimum 1 year).
Condition or domain being studied
The aim of this project is to systematically evaluate the gender-related comparative effectiveness and safety of pharmacotherapy versus lifestyle modification in prevention of diabetes manifestation in prediabetics.
Impaired fasting glucose (IFG) as well as impaired glucose tolerance (IGT), isolated or combined, are precursors of a diabetic metabolic status and often persist years before diagnosis of type II diabetes. Gender-specific and age-related differences in IFG and IGT frequency have been observed, which may delay diabetes diagnosis and individual risk factor detection. Diabetes preventive actions have been studied in depth, but gender-specific differences in efficacy were rarely taken into account. To fill this knowledge gap the current review focuses on the gender-specific differences.
People with prediabetes/pre-diabetic state aged between 25 and 70 years:
• Impaired fasting glucose (IFG): elevated fasting blood glucose level from 5.6 mmol/L (100 mg/dL) to 6.9 mmol/L (125 mg/dL)
• Impaired glucose tolerance (IGT): two-hour glucose levels of 140 to 199 mg per dL (7.8 to 11.0 mmol) on the 75-g oral glucose tolerance test. A patient is said to be under the condition of IGT when he/she has an intermediately raised glucose level after 2 hours, but less than would qualify for type 2 diabetes mellitus.
Women with gestational diabetes are excluded for lack of a corellating male control group.
Sex-specific differences in the Incidence of Diabetes Mellitus manifestation (fasting blood glucose level > 126 mg/dl, oral glucose tolerance test: 2 hours postprandial glucose level > 200 mg/dl)
Sex-specific differences of health related quality of life
Sex-specific differences in adverse events
Sex-specific differences in morbidity and mortality
Data extraction, (selection and coding)
We will use standardized data extraction forms into which trained reviewers abstract data from each study and assign an initial rating of the risk of bias. A senior reviewer will evaluate the forms.
Risk of bias (quality) assessment
All eligible studies will be dually reviewed based on the Cochrane Risk of Bias Tool.
To assess the risk of bias of observational studies, we employ criteria outlined by Deeks et al., for systematic reviews we use the AMSTAR (Assessment of Multiple Systematic Reviews) tool.
The strength of evidence for the most important outcomes will be assessed according to GRADE (Grading of Recommendations Assessment, Development and Evaluation) tool.
Strategy for data synthesis
A descriptive analysis of all selected studies, which address our predefined key question will be provided. When data on a particular outcome of interest are sufficient, we plan to conduct a meta-analysis of the odds ratio of experiencing an event.
Analysis of subgroups or subsets
Subgroup-Analysis for all key questions:
Patients with metabolic syndrome according to the WHO-definition:
• Hypertension: if blood pressure = 140/90 mmHg
• Dyslipidaemia: tryglicerides > 1.695 mmol/l, HDL = men 0.9 mmol/l, women = 1.0 mmol/l
• Visceral adipositas: waist-hip ratio for men > 0.9, for women > 0.85 and/or a BMI > 30 kg/m2
Contact details for further information
Danube University Krems
Department for Evidence-based Medicine and Clinical Epidemiology
3500 Krems an der Donau
Organisational affiliation of the review
Medical University of Vienna & Danube University Krems
www.meduniwien.ac.at and http://www.donau-uni.ac.at
Dr Anna Glechner, Danube University Krems Dr Juergen Harreiter, Medical University of Vienna Dr Sonja Rohleder, Danube University Krems & Medical University of Vienna Mr Alexander Kautzky, Medical University of Vienna Mrs Megan Grace Van Noord, Danube University Krems Dr Angela Kaminski - Hartenthaler, Danube University Krems Professor Gerald Gartlehner, Danube University Krems Professor Jaako Tuomilehto, Danube University Krems & University of Helsinki Professor Alexandra Kautzky - Willer, Medical University of Vienna
Anticipated or actual start date
18 September 2012
Anticipated completion date
18 September 2013
Medizinisch-Wissenschaftlicher Fonds des Bürgermeisters der Bundeshauptstadt Wien (Medical-Scientific Foundation of the Major of the Federal Capital Vienna)
Conflicts of interest
Subject index terms status
Subject indexing assigned by CRD
Subject index terms
Diabetes Mellitus; Health Promotion; Humans; Hypoglycemic Agents; Life Style; Primary Prevention; Sex Factors
Date of registration in PROSPERO
16 October 2012
Date of publication of this revision
30 October 2012
Stage of review at time of this submission
Piloting of the study selection process
Formal screening of search results against eligibility criteria
Risk of bias (quality) assessment
PROSPERO This information has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. CRD bears no responsibility or liability for the content of this registration record, any associated files or external websites.