Evidence based medicine

1.

Volgograd State Medical University
“Evidence Based Medicine”
Егаез Ахмед елсайед
Group 6-46

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PICO Question: In individuals diagnosed with
Diabetes Mellitus, what is the impact of
implementing a Ketogenic Diet compared to a
standard diet or other dietary interventions on
blood glucose levels?
Population: Individuals diagnosed with Diabetes
Mellitus
Intervention:Implementation of a Ketogenic Diet
Comparison: Standard diet or other dietary
interventions
Outcome: Impact on blood glucose levels

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To compare the effects of a low-carbohydrate, ketogenic
diet program with those of a low-fat, low-cholesterol,
reduced calorie diet.
Methods and Materials:
Healthy persons were recruited from the
community. Inclusion criteria were age 18 to 65 years,
body mass index of 30 to 60 kg/m2 desire to lose weight,

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Introduction:The ketogenic diet (KD) is characterized by fat as a
substitute of carbohydrates for the primary energy
source. There is a large number of overweight or obese people
with type 2 diabetes mellitus (T2DM), while this study
aims to observe periodic ketogenic diet for efect on overweight or
obese patients newly diagnosed as T2DM.
Methods: A total of 60 overweight or obese patients newly
diagnosed as T2DM were randomized into two groups:
KD group, which was given ketogenic diet, and control group,
which was given routine diet for diabetes, 30 cases
in each group. Both dietary patterns lasted 12 weeks, and during
the period, the blood glucose, blood lipid, body
weight, insulin, and uric acid before and after intervention, as well
as the signifcance for relevant changes, were observed.

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Results: For both groups, the weight, BMI(body mass index), Waist, TG
(triglyceride), TC(cholesterol), LDL (low-density
lipoprotein cholesterol), HDL (high-density lipoprotein cholesterol), FBG (fasting
glucose), FINS (fasting insulin), HbA1c
(glycosylated hemoglobin) were decreased after intervention (P < 0.05), while
the decrease rates in the KD group was
more signifcant than the control group. However, UA(serum uric acid) in the KD
group showed an upward trend,
while in the control group was not changed signifcantly (P > 0.05).The
willingness to adhere to the ketogenic diet
over the long term was weaker than to the routine diet for diabetes.
Conclusion: Among the overweight or obese patients newly diagnosed as type 2
diabetes mellitus, periodic
ketogenic diet can not only control the body weight, but also control blood
glucose and lipid, but long-term persistence
is difficult

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Methods
The present meta-analysis is reported in accordance with the
Preferred Reporting Items for Systematic Reviews and MetaAnalyses
(PRISMA) Statement(13). The protocol was previously
published in the PROSPERO database (http://www.crd.york.
ac.uk/PROSPERO), under registration no. CRD42012002408.
Conclusion :
The present meta-analysis showed that individuals assigned to
a VLCKD achieve greater reductions in body weight, TAG
and DBP, but they also demonstrate a greater increase in
LDL-C and HDL-C levels over a treatment follow-up period
of 12 months or more, compared with individuals assigned
to a LFD. Only the change in HDL-C levels retained statistical
significance in the subgroup analysis of studies with 24
months of follow-up; however, it is important to note that
this analysis included only four studies. With regard to the primary
outcome, the present findings are similar to the findings of previous
meta-analyses(10,11).
The supposed beneficial effect of a VLCKD on body weight
may be due to the modulation of resting energy expenditure.

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Methods
Participants recruited to the UKPDS
Details are presented in the companion paper
(UKPDS 36) published in this issue (see page 412).
Participants in observational analysis
Of 5102 patients, 4585 white, Asian Indian, and
Afro-Caribbean patients who had haemoglobin A1c
(HbA1c) measured three months after the diagnosis of
diabetes were included in analyses of incidence rates.
Of these, 3642 with complete data for potential
confounders were included in analyses of relative risk.
Complete data were required for all participants
included in the multivariate observational analyses. For
this reason there are fewer (3642) participants in these
analyses than in the clinical trial, despite the inclusion
of patients not randomised in the trial.
Conclusion: This observational analysis shows highly significant
associations between the development of each of the
complications of diabetes, including mortality, across
the wide range of exposure to glycaemia that occurs in
patients with type 2 diabetes. This association microvascular complications
seen in populations with less satisfactory control of glycaemia.

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RCT 1 Assessment
Selection bias : Low risk
Sequence generation : low risk of bias
Allocation concealment : low risk of bias
Generally healthy persons were recruited from the
Community. Inclusion criteria were age 18 to 65 years,
Body mass index of 30 to 60 kg/m2
, desire to lose weight,
Elevated lipid levels (total cholesterol level 5.17 mmol/L
[200 mg/dL], low-density lipoprotein [LDL] cholesterol
Level 3.36 mmol/L [130 mg/dL], or triglyceride level
2.26 mmol/L [200 mg/dL]), and no serious medical
Condition.

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PERFORMANCE BIAS : high risk of bias
All participants provided written informed consent,
and the institutional review board of Duke University
Health System approved the study.
By using a computer-generated simple randomization
List, participants were allocated to receive the lowcarbohydrate
Diet or low-fat diet. The intervention for both groups
Included group meetings, diet instruction, and an exercise
Recommendation. Group meetings took place at an outpatient
Research clinic twice monthly for 3 months, then
Monthly for 3 months. These meetings typically lasted 1
Hour and consisted of diet instruction, supportive counseling,
Questionnaires, and biomedical measurements. During
The study, participants selected their own menus and
prepared
Or bought their own meals according to the guidelines

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Detection Bias : High risk of bias
For all primary and secondary continuous
outcomes, linear mixed-effects models (PROC MIXED
procedure in SAS software) that included fixed and random
effects were used to determine expected mean values
at each time point and to test hypotheses of group differences.
In most body weight and body composition models,
time and group assignment were included as fixed effects
with linear and quadratic time-by-group interaction terms.
In the fat-free mass, total body water, and vital sign models,
the time-by-group interaction was treated as a categorical
variable. In all body weight and body composition
models, random effects included intercept and linear slope
terms. For the serum outcome measure models, the timeby-group
interaction was treated as a categorical variable,
and an unstructured covariance was used to account for
within-patient correlation time

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ATTRITION BIAS: High risk :
Forty-five (76%) of the 59 participants originally assigned
To the low-carbohydrate diet group and 34 (57%) of
The 60 participants assigned to the low-fat diet group completed
The study (P 0.02). In the low-carbohydrate diet
Group, 4 participants (7%) could not adhere to the group
Meeting schedule, 5 (8%) could not adhere to the diet, 1
(2%) was unsatisfied with weight loss, 3 (5%) dropped out
Because of adverse effects, and 1 (2%) was lost to followup.
Of the 3 participants who dropped out because of
Adverse effects, 2 had increases in LDL cholesterol level,
And 1 experienced shakiness and uneasiness. In the low-fat
Diet group, 15 participants (25%) could not adhere to the
Group meeting schedule, 3 (5%) could not adhere to the group.
REPORTING BIAS: not found
OTHER BIAS Not found

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Conclusions: Compared with a low-fat
diet, a low-carbohydrate
diet program had better participant
retention and greater weight
loss. During active weight loss, serum
triglyceride levels decreased
more and high-density lipoprotein
cholesterol level increased more
with the low-carbohydrate diet than with
the low-fat diet

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The End