EAL

PDM: Prediabetes (2013)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

The purpose of this paper was to evaluate the effect after one year of the life-style intervention program on glucose tolerance and insulin resistance in subjects at risk for developing type 2 diabetes. Total study duration was 3 years.

Inclusion Criteria:

>40 years old
Family history of diabetes or body mass index (BMI) =/> 25 kg/m²
Two oral glucose-tolerance results of fasting glucose <7.8 mM and 2-hour glucose concentration between 7.8 and 12.5 mM

Exclusion Criteria:

Known or overt diabetes
Previously diagnosed diabetes
Medication use known to interfere with glucose tolerance
Participation in regular vigorous exercise program
Participation in intensive weight reduction program during the last year before the study
Any disease that makes participation in a lifestyle-intervention program impossible
Improbably 5 year survival

Description of Study Protocol:

Recruitment

Subjects were selected from an existing cohort which was described in another paper

Design

Randomized controlled trial

Blinding used (if applicable)

Intervention (if applicable)

Intervention group participated in regularly scheduled dietary and physical activity visits throughout the study. Dietitians instructed individual subjects on recommendations for healthy eating based on the Dutch Nutrition Council guidelines. Subjects were encouraged to increase their activity to 30 minutes of moderate physical activity at least 5 days per week. Visits were scheduled at randomization, in 4-6 weeks after randomization, and then every 3 months.
Control group participants were given written information about diet and exercise but no individual programs were given. Visits were only at randomization and yearly for annual measurements.

Statistical Analysis

Data is presented in mean ± SE
Differences between baseline and 1 year between groups were analyzed with an unpaired t-test
Two-tailed paired t-test was used to analyze differences within groups between baseline and 1 year
Univariate and stepwise regression analyses were performed to identify the contribution of changes in lifestyle and anthropometric factors to changes in glucose tolerance and insulin resistance in the intervention group.

Data Collection Summary:

Timing of Measurements

Baseline and 1 year

Dependent Variables

Glucose tolerance
Insulin resistance

Independent Variables

Study group

Control Variables

Lifestyle and anthropometric factors

Description of Actual Data Sample:

Initial N: 114

Attrition (final N): 102 (58 men/44 women)

Age: 55 ± 1 years intervention group/ 58 ± 1 years control group

Ethnicity: Dutch

Other relevant demographics: BMI was 29 in both groups at baseline

Anthropometrics: Both groups were similar in baseline measurements

Location: The Netherlands

Summary of Results:

**Results: 1-year change (n=102)**
	Intervention Group	Control Group	p value
2-hour glucose (mM)*	-0.8 ± 0.3	+0.2 ± 0.3	<0.05
FPG (mM)	-0.1 ± 0.1	+0.1 ± 0.1	NS
HOMA	-0.72 ± 0.29	+0.14 ± 0.18	<0.05
A1C (%)	-0.2 ± 0.1	-0.1 ± 0.1	NS
BMI	-0.9 ± 0.2	-0.0 ± 0.2	<0.001
Aerobic capacity (VO₂Max: L/min)	+0.10 ± 0.03	-0.00 ± 0.03	<0.05

*1 mM of measured blood glucose is equivalent to 18 mg/dl measured blood glucose

Other Findings

Baseline nutrient intake between groups was comparable in energy, macronutrient, alcohol and fiber. At 1 year, the intervention group had increased their carbohydrate and fiber intake and decreased their total fat intake (p<0.001).
Based on regression analysis, change in weight, BMI and VO_2max correlated with change in glucose tolerance. Change in weight, body composition, aerobic capacity and nutrient intake were related to changes in insulin resistance.

Author Conclusion:

Our study shows that a lifestyle-intervention program according to general recommendations is effective and improves glucose tolerance in subjects with IGT, thereby reducing the risk of progression of type 2 diabetes.

Funding Source:

Reviewer Comments:

The control group received an intervention, although minimal.

Quality Criteria Checklist: Primary Research
Relevance Questions
	1.	Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies)	Yes
	2.	Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about?	Yes
	3.	Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice?	Yes
	4.	Is the intervention or procedure feasible? (NA for some epidemiological studies)	Yes

Validity Questions
1.	Was the research question clearly stated?		Yes
	1.1.	Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified?	Yes
	1.2.	Was (were) the outcome(s) [dependent variable(s)] clearly indicated?	Yes
	1.3.	Were the target population and setting specified?	Yes
2.	Was the selection of study subjects/patients free from bias?		???
	2.1.	Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study?	Yes
	2.2.	Were criteria applied equally to all study groups?	Yes
	2.3.	Were health, demographics, and other characteristics of subjects described?	Yes
	2.4.	Were the subjects/patients a representative sample of the relevant population?	???
3.	Were study groups comparable?		Yes
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	Yes
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	Yes
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	Yes
	3.4.	If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis?	N/A
	3.5.	If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.)	N/A
	3.6.	If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")?	N/A
4.	Was method of handling withdrawals described?		Yes
	4.1.	Were follow-up methods described and the same for all groups?	No
	4.2.	Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.)	Yes
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	Yes
	4.4.	Were reasons for withdrawals similar across groups?	Yes
	4.5.	If diagnostic test, was decision to perform reference test not dependent on results of test under study?	N/A
5.	Was blinding used to prevent introduction of bias?		No
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	No
	5.2.	Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.)	No
	5.3.	In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?	N/A
	5.4.	In case control study, was case definition explicit and case ascertainment not influenced by exposure status?	N/A
	5.5.	In diagnostic study, were test results blinded to patient history and other test results?	N/A
6.	Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described?		Yes
	6.1.	In RCT or other intervention trial, were protocols described for all regimens studied?	Yes
	6.2.	In observational study, were interventions, study settings, and clinicians/provider described?	N/A
	6.3.	Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?	Yes
	6.4.	Was the amount of exposure and, if relevant, subject/patient compliance measured?	Yes
	6.5.	Were co-interventions (e.g., ancillary treatments, other therapies) described?	No
	6.6.	Were extra or unplanned treatments described?	No
	6.7.	Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?	Yes
	6.8.	In diagnostic study, were details of test administration and replication sufficient?	N/A
7.	Were outcomes clearly defined and the measurements valid and reliable?		Yes
	7.1.	Were primary and secondary endpoints described and relevant to the question?	Yes
	7.2.	Were nutrition measures appropriate to question and outcomes of concern?	Yes
	7.3.	Was the period of follow-up long enough for important outcome(s) to occur?	Yes
	7.4.	Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?	Yes
	7.5.	Was the measurement of effect at an appropriate level of precision?	Yes
	7.6.	Were other factors accounted for (measured) that could affect outcomes?	No
	7.7.	Were the measurements conducted consistently across groups?	Yes
8.	Was the statistical analysis appropriate for the study design and type of outcome indicators?		Yes
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	Yes
	8.2.	Were correct statistical tests used and assumptions of test not violated?	Yes
	8.3.	Were statistics reported with levels of significance and/or confidence intervals?	Yes
	8.4.	Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)?	No
	8.5.	Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?	Yes
	8.6.	Was clinical significance as well as statistical significance reported?	???
	8.7.	If negative findings, was a power calculation reported to address type 2 error?	N/A
9.	Are conclusions supported by results with biases and limitations taken into consideration?		No
	9.1.	Is there a discussion of findings?	No
	9.2.	Are biases and study limitations identified and discussed?	No
10.	Is bias due to study's funding or sponsorship unlikely?		Yes
	10.1.	Were sources of funding and investigators' affiliations described?	Yes
	10.2.	Was the study free from apparent conflict of interest?	Yes