EAL

DM: Carbohydrates (2007)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

To compare the glycemic response of traditonal "sucrose-free" meals and snacks with the glycemic responses of sucrose-containing meals and snacks throughout the day.
To obtain short-term feasibility and safety data concerning sucrose-containing diets for children with IDDM.

Inclusion Criteria:

average total stable HbA1c of 10.0% or less for 6 months before the study
complete dependence on insulin: daily insulin dose of 0.8U/kg or greater
weight and height between the 25th and 90th percentiles on NCHS growth charts
prepubertal or Tanner puberty stage 1 or 2
absence of familial hyperlipidemia
untreated hypothyroidism

Exclusion Criteria:

Excluded if not included above.

Description of Study Protocol:

Recruitment not specified

Design 4-day study in hospital; 2-day trial of each diet in random order

Blinding used (if applicable): not possible

Intervention (if applicable)

Diets (isocaloric; 50% CHO, 20% protein, 30% fat)

Sucrose-Free: 10±1 g sucrose per day (2% of calories)
Sucrose-Con: 52±2 gm sucrose (10% of calories)

Statistical Analysis

two-factor repeated measures analysis of variance performed to determine whether there was an order effect between the two diets for glucose measures
two-tailed t-test used tod etermine whether there was a difference in the area under the glucose response curve between the 2 days of each diet type: no difference found
one-tailed paired t-test used to compare the means of the two diet periods for each variable

Data Collection Summary:

Timing of Measurements

blood samples drawn immediately before each meal or snack and at 30 min and 1 hour
24-hour urine samples taken each day

Dependent Variables

blood glucose and urinary glucose concentration using a colorimetric glucose oxidase method
HbA1c using a cation exchange procedure
daily total area under the glucose reponse curve from 8 am to 9:30 pm

Independent Variables

Diets (isocaloric; 50% CHO, 20% protein, 30% fat)
- Sucrose-Free: 10±1 g sucrose per day (2% of calories)
- Sucrose-Con: 52±2 gm sucrose (10% of calories)
food intake measured by weighed food intake records

Control Variables

food intake- all meals prepared in research kitchen
insulin dose and regulation
exercise and activity

Description of Actual Data Sample:

Initial N:10; 4 girls

Attrition (final N): 10

Age: 7-12 years

Ethnicity: not specified

Other relevant demographics: median duration of diabetes 5y 5 mo; mean of average HbA1c 8.9±0.3

Anthropometrics : all children had weights and heights between the 25th and 90th percentiles

Location: United States

Summary of Results:

Variables	Suc-Free Group	Suc-Con Group	P
Blood glucose concentration, baseline before 6 meals/snacks, mg/dl	244±25	233±18	0.56
Blood glucose concentration at 30 min	259±15	252±19	0.69
Blood glucose concentration at 1 hour	278±16	277±21	0.97
Total area under the glucose response curve (mg/dl) per hour for 6 meals/snack	3672±240	3574±285	0.74
urinary glucose excretion, gm/24 hr	35.6±7.5	34.5±7.5	0.84

Other Findings

The postprandial glucose response adjusted for baseline concentrations at each meal and snack duirng the two diet periods did not differ (P>0.10).

Incidence of mild hypoglycemia during the two periods was the same (7 for each).

The incidence of hyperglycemia (<300 mg/dl) was two for the Suc-Free diet period and one for the Suc-Con diet period.

Author Conclusion:

Up to 10% of the total number of kilcalories allowed per day can be ingested as scurose without adverse glycemic effects when included in mixed meals and snacks that are a part of an integrated insulin, diet, and exercise management program for children with diabetes mellitus.

Funding Source:

Government:

GCRC, NIH

Industry:

Hershey

Food Company:

University/Hospital:

Diabetes Research and Training Center

Reviewer Comments:

Diet intake and physical activity were very closely controlled in this study.

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?		Yes
	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?	N/A
	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?	Yes
3.	Were study groups comparable?		N/A
	3.1.	Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)	N/A
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	N/A
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	N/A
	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?	Yes
	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?	N/A
	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?		Yes
	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.)	Yes
	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?	Yes
	6.6.	Were extra or unplanned treatments described?	N/A
	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?	Yes
	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)?	N/A
	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?	Yes
	8.7.	If negative findings, was a power calculation reported to address type 2 error?	Yes
9.	Are conclusions supported by results with biases and limitations taken into consideration?		Yes
	9.1.	Is there a discussion of findings?	Yes
	9.2.	Are biases and study limitations identified and discussed?	Yes
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