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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.

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?

SUBMITTER: Saslow LR

PROVIDER: S-EPMC5865541 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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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.

Saslow Laura R LR Daubenmier Jennifer J JJ Moskowitz Judith T JT Kim Sarah S Murphy Elizabeth J EJ Phinney Stephen D SD Ploutz-Snyder Robert R Goldman Veronica V Cox Rachel M RM Mason Ashley E AE Moran Patricia P Hecht Frederick M FM

Nutrition & diabetes 20171221 12

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 o ...[more]

PMID: 29269731

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Project description:BackgroundType 2 diabetes is a prevalent, chronic disease for which diet is an integral aspect of treatment. In our previous trial, we found that recommendations to follow a very low-carbohydrate ketogenic diet and to change lifestyle factors (physical activity, sleep, positive affect, mindfulness) helped overweight people with type 2 diabetes or prediabetes improve glycemic control and lose weight. This was an in-person intervention, which could be a barrier for people without the time, flexibility, transportation, social support, and/or financial resources to attend.ObjectiveThe aim was to determine whether an online intervention based on our previous recommendations (an ad libitum very low-carbohydrate ketogenic diet with lifestyle factors; "intervention") or an online diet program based on the American Diabetes Associations' "Create Your Plate" diet ("control") would improve glycemic control and other health outcomes among overweight individuals with type 2 diabetes.MethodsIn this pilot feasibility study, we randomized overweight adults (body mass index ≥25) with type 2 diabetes (glycated hemoglobin [HbA1c] 6.5%-9.0%) to a 32-week online intervention based on our previous recommendations (n=12) or an online diet program based around a plate method diet (n=13) to assess the impact of each intervention on glycemic control and other health outcomes. Primary and secondary outcomes were analyzed by mixed-effects linear regression to compare outcomes by group.ResultsAt 32 weeks, participants in the intervention group reduced their HbA1c levels more (estimated marginal mean [EMM] -0.8%, 95% CI -1.1% to -0.6%) than participants in the control group (EMM -0.3%, 95% CI -0.6% to 0.0%; P=.002). More than half of the participants in the intervention group (6/11, 55%) lowered their HbA1c to less than 6.5% versus 0% (0/8) in the control group (P=.02). Participants in the intervention group lost more weight (EMM -12.7 kg, 95% CI -16.1 to -9.2 kg) than participants in the control group (EMM -3.0 kg, 95% CI -7.3 to 1.3 kg; P<.001). A greater percentage of participants lost at least 5% of their body weight in the intervention (10/11, 90%) versus the control group (2/8, 29%; P=.01). Participants in the intervention group lowered their triglyceride levels (EMM -60.1 mg/dL, 95% CI -91.3 to -28.9 mg/dL) more than participants in the control group (EMM -6.2 mg/dL, 95% CI -46.0 to 33.6 mg/dL; P=.01). Dropout was 8% (1/12) and 46% (6/13) for the intervention and control groups, respectively (P=.07).ConclusionsIndividuals with type 2 diabetes improved their glycemic control and lost more weight after being randomized to a very low-carbohydrate ketogenic diet and lifestyle online program rather than a conventional, low-fat diabetes diet online program. Thus, the online delivery of these very low-carbohydrate ketogenic diet and lifestyle recommendations may allow them to have a wider reach in the successful self-management of type 2 diabetes.Trial registrationClinicalTrials.gov NCT01967992; https://clinicaltrials.gov/ct2/show/NCT01967992 (Archived by WebCite at http://www.webcitation.org/6o0fI9Mkq).

Project description:BackgroundConventional mechanical or alcohol-assisted photorefractive keratectomy (PRK) techniques for correction of hyperopia and hyperopic astigmatism were associated with inconsistent results. The aim of this study is to evaluate the 12-month visual and refractive outcomes of the relatively new single-step transepithelial photorefractive keratectomy (TE-PRK) for moderate hyperopia and hyperopic astigmatism.MethodsThis is a prospective interventional study. Forty-eight eyes of 30 patients with moderate hyperopia or hyperopic astigmatism with a cycloplegic spherical equivalent refraction (SEQ) between 2.0 and 4.5 diopters (D) underwent single-step StreamLight® TE-PRK using EX500 excimer laser (Alcon Laboratories, USA). The main outcome measures were recorded at 6 and 12 months postoperatively including assessment of logarithm of the minimum angle resolution (logMAR) uncorrected and corrected distance visual acuity (UDVA, CDVA), cycloplegic refraction, corneal topographic changes as well as post-PRK peripheral haze grading.ResultsThe mean preoperative cycloplegic SEQ was significantly reduced from 3.21 ± 0.61 D to 0.35 ± 0.04 D and 0.41 ± 0.04 D at 6 and 12 months, respectively (P < 0.001). The mean preoperative UDVA significantly improved from 0.53 ± 0.02 logMAR to 0.07 ± 0.01 logMAR and 0.08 ± 0.01 logMAR at 6 and 12 months, respectively (P < 0.001) while the mean preoperative logMAR CDVA showed non-significant change over time throughout the study (P = 0.135). At the end of the study, 41 eyes (85.4%) achieved UDVA of 20/25 or better and no eye lost any lines of CDVA. Thirty-eight eyes (79.1%) had a postoperative cycloplegic cylinder of 0.5 D or less at 12 months. The mean preoperative mean keratometry showed significant increase at 6 and 12 months postoperatively (P < 0.001) while there was no significant change between the two postoperative visits denoting topographic stability (P = 0.058). The mean postoperative Q value at 6 and 12 months showed a significant prolate shift (P < 0.001). No haze was observed in 62.5% and 85.4% of the enrolled eyes at 6 and 12 months, respectively.ConclusionsSingle-step StreamLight® TE-PRK for moderate hyperopia and hyperopic astigmatism achieved acceptable visual and refractive outcomes.Trial registration(Clinicaltrials.gov): NCT05261685, 2 March 2022, retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT05261685.

Project description:BackgroundConsensus has not been reached on what constitutes an optimal diet in individuals with prediabetes and type 2 diabetes mellitus (T2DM), especially between low-carbohydrate options.ObjectivesWe compared 2 low-carbohydrate diets with 3 key similarities (incorporating nonstarchy vegetables and avoiding added sugars and refined grains) and 3 key differences (incorporating compared with avoiding legumes, fruits, and whole, intact grains) for their effects on glucose control and cardiometabolic risk factors in individuals with prediabetes and T2DM.MethodsKeto-Med was a randomized, crossover, interventional trial. Forty participants aged ≥18 years with prediabetes or T2DM followed the well-formulated ketogenic diet (WFKD) and the Mediterranean-plus diet (Med-Plus) for 12 weeks each, in random order. The diets shared the 3 key similarities noted above. The Med-Plus incorporated legumes, fruits, and whole, intact grains, while the WFKD avoided them. The primary outcome was the percentage change in glycated hemoglobin (HbA1c) after 12 weeks on each diet. Secondary and exploratory outcomes included percentage changes in body weight, fasting insulin, glucose, and blood lipids; average glucose from continuous glucose monitor (CGM), and nutrient intake.ResultsThe primary analysis was of 33 participants with complete data. The HbA1c values did not differ between diets at 12 weeks. Triglycerides decreased more for the WFKD [percentage changes, -16% (SEM, 4%) compared with -5% (SEM, 6%) for the Med-Plus; P = 0.02] and LDL cholesterol was higher for the WFKD [percentage changes, +10% (SEM, 4%) compared with -5% (SEM, 5%) for the Med-Plus; P = 0.01]. Weight decreased 8% (SEM, 1%) compared with 7% (SEM, 1%) and HDL cholesterol increased 11% (SEM, 2%) compared with 7% (SEM, 3%) for the WFKD compared with the Med-Plus, respectively; however, there was a significant interaction of diet × order for both. Participants had lower intakes of fiber and 3 nutrients on the WFKD compared with the Med-Plus. Twelve-week follow-up data suggest the Med-Plus is more sustainable.ConclusionsHbA1c values were not different between diet phases after 12 weeks, but improved from baseline on both diets, likely due to several shared dietary aspects. The WFKD led to a greater decrease in triglycerides, but also had potential untoward risks from elevated LDL cholesterol and lower nutrient intakes from avoiding legumes, fruits, and whole, intact grains, as well as being less sustainable. This trial was registered at clinicaltrials.gov as NCT03810378.

Project description:BackgroundThe Center for Disease Control and Prevention's National Diabetes Prevention Program (NDPP) aims to help individuals with prediabetes avoid progression to type 2 diabetes mellitus (T2DM) through weight loss. Specifically, the NDPP teaches individuals to follow a low-fat, calorie-restricted diet and to engage in regular physical activity to achieve ≥ 5% body weight loss. Most NDPP participants, however, do not achieve this weight loss goal, and glycemic control remains largely unchanged. One promising opportunity to augment the NDPP's weight loss and glycemic effectiveness may be to teach participants to follow a very low-carbohydrate diet (VLCD), which can directly reduce post-prandial glycemia and facilitate weight loss by reducing circulating insulin and enabling lipolysis. To date, there have been no high-quality, randomized controlled trials to test whether a VLCD can prevent progression to T2DM among individuals with prediabetes. The aim of this study is to test the effectiveness of a VLCD version the NDPP (VLC-NDPP) versus the standard NDPP. We hypothesize the VLC-NDPP will demonstrate greater improvements in weight loss and glycemic control.MethodsWe propose to conduct a 12-month, 1:1, randomized controlled trial that will assign 300 adults with overweight or obesity and prediabetes to either the NDPP or VLC-NDPP. The primary outcome will be glycemic control as measured by change in hemoglobin A1c (HbA1c) from baseline to 12 months. Secondary outcomes will include percent body weight change and changes in glycemic variability, inflammatory markers, lipids, and interim HbA1c. We will evaluate progression to T2DM and initiation of anti-hyperglycemic agents. We will conduct qualitative interviews among a purposive sample of participants to explore barriers to and facilitators of dietary adherence. The principal quantitative analysis will be intent-to-treat using hierarchical linear mixed effects models to assess differences over time.DiscussionThe NDPP is the dominant public health strategy for T2DM prevention. Changing the program's dietary advice to include a carbohydrate-restricted eating pattern as an alternative option may enhance the program's effectiveness. If the VLC-NDPP shows promise, this trial would be a precursor to a multi-site trial with incident T2DM as the primary outcome.Trial registrationNCT05235425. Registered February 11, 2022.

Dataset Information

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.

Publications

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.

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