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Twelve-month outcomes of a randomized trial of a moderate-carbohydrate versus very low-carbohydrate diet in overweight adults with type 2 diabetes mellitus or prediabetes.

Nutrition & diabetes
January 1, 1970
Laura R Saslow et al. (12 authors)
Journal ArticleRandomized Controlled TrialResearch Support, N.I.H., ExtramuralResearch Support, Non-U.S. Gov'tHuman StudyClinical
Study Details

Study Goal

The researchers aimed to compare the effects of a very low-carbohydrate ketogenic (LCK) diet versus a moderate-carbohydrate, calorie-restricted, low-fat (MCCR) diet on HbA1c levels, weight loss, and medication use in adults with elevated HbA1c and body weight.

Results Summary

The LCK diet group showed significantly greater reductions in HbA1c levels, more weight loss, and higher rates of diabetes-related medication discontinuation compared to the MCCR diet group after 12 months.

Population

Adults with glycated hemoglobin (HbA1c) > 6.0% and elevated body weight (BMI > 25).

Effective Dosage

Not specified

Duration

12 months

Interactions

None mentioned

Extracted Claims (5)
InterventionDirectionEndpointPopulationDosageImpactClaim #
very low-carbohydrate ketogenic (LCK) diet
decrease
HbA1c levels
adults with glycated hemoglobin (HbA1c) > 6.0% and elevated body weight (BMI > 25)
estimated marginal mean (EMM) at baseline = 6.6%, at 12 mos = 6.1%
had greater reductions in
#1
very low-carbohydrate ketogenic (LCK) diet
decrease
weight
adults with glycated hemoglobin (HbA1c) > 6.0% and elevated body weight (BMI > 25)
estimated marginal mean (EMM) at baseline = 99.9 kg, at 12 mos = 92.0 kg
lost more
#2
very low-carbohydrate ketogenic (LCK) diet
decrease
diabetes-related medication use
adults with glycated hemoglobin (HbA1c) > 6.0% and elevated body weight (BMI > 25)
6/10 in the LCK group discontinued these medications compared with 0/6 in the MCCR group
experienced larger reductions in
#3
moderate-carbohydrate, calorie-restricted, low-fat (MCCR) diet
decrease
HbA1c levels
adults with glycated hemoglobin (HbA1c) > 6.0% and elevated body weight (BMI > 25)
estimated marginal mean (EMM) at baseline = 6.9%, at 12 mos = 6.7%
had reductions in
#4
moderate-carbohydrate, calorie-restricted, low-fat (MCCR) diet
decrease
weight
adults with glycated hemoglobin (HbA1c) > 6.0% and elevated body weight (BMI > 25)
estimated marginal mean (EMM) at baseline = 97.5 kg, at 12 mos = 95.8 kg
lost
#5
Abstract

Dietary treatment is important in management of type 2 diabetes or prediabetes, but uncertainty exists about the optimal diet. We randomized adults (n = 34) with glycated hemoglobin (HbA1c) > 6.0% and elevated body weight (BMI > 25) to a very low-carbohydrate ketogenic (LCK) diet (n = 16) or a moderate-carbohydrate, calorie-restricted, low-fat (MCCR) diet (n = 18). All participants were encouraged to be physically active, get sufficient sleep, and practice behavioral adherence strategies based on positive affect and mindful eating. At 12 months, participants in the LCK group had greater reductions in HbA1c levels (estimated marginal mean (EMM) at baseline = 6.6%, at 12 mos = 6.1%) than participants in MCCR group (EMM at baseline = 6.9%, at 12 mos = 6.7%), p = .007. Participants in the LCK group lost more weight (EMM at baseline = 99.9 kg, at 12 mos = 92.0 kg) than participants in the MCCR group (EMM at baseline = 97.5 kg, at 12 mos = 95.8 kg), p < .001. The LCK participants experienced larger reductions in diabetes-related medication use; of participants who took sulfonylureas or dipeptidyl peptidase-4 inhibitors at baseline, 6/10 in the LCK group discontinued these medications compared with 0/6 in the MCCR group (p = .005). In a 12-month trial, adults with elevated HbA1c and body weight assigned to an LCK diet had greater reductions in HbA1c, lost more weight, and reduced more medications than those instructed to follow an MCCR diet.

Medical Subject Headings (MeSH)
AdolescentAdultBlood GlucoseCholesterolDiabetes Mellitus, Type 2Diet, Carbohydrate-RestrictedDiet, KetogenicDietary CarbohydratesFemaleGlycated HemoglobinHumansMaleMiddle AgedObesityPrediabetic StateTreatment OutcomeWeight LossYoung Adult
Study Links
Quality Scores
SafetyNot Assessed
Efficacy85/10
Quality75/10
Citation Metrics
Total Citations147
Citations/Year18.4
Relative Citation Ratio6.41
NIH Percentile95.4%
Research Impact Scores
APT Score0.95
Weight Score1.92
Normalized Score0.69
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