Dataset Information

Evaluation of the efficacy of simplified nutritional instructions from physicians on dietary salt restriction for patients with type 2 diabetes mellitus consuming excessive salt: protocol for a randomized controlled trial.

ABSTRACT:

Background

Hypertension is present in more than 50% of patients with type 2 diabetes mellitus. Dietary salt restriction is recommended for the management of high blood pressure. Instructions on dietary salt restriction, provided by a dietitian, have been shown to help patients reduce their salt intake. However, appointments for the dietitians in hospitals are often already fully booked, making it difficult for patients to receive instructions on the same day as the outpatient clinic visit.

Aim

The aim of this trial is to test a new intervention to assess whether guidance on dietary salt restriction provided by physicians during outpatient visits is effective in reducing salt intake in patients with type 2 diabetes mellitus who have an excessive salt intake.

Methods

In this unblinded randomized controlled trial (RCT), a total of 200 patients, male or female, aged between 20?and 90?years, who have type 2 diabetes mellitus and consume excessive salt will be randomly assigned to two groups: an intervention group and a control group. In addition to being given routine treatment, participants in the intervention group will be given individual guidance on restricting their dietary salt intake by a physician upon enrollment. The control group will only be given routine treatment. Participants will be followed up for 24?weeks. The primary outcome will be dietary salt intake, which will be assessed at baseline and at 8, 16, and 24?weeks. The secondary outcomes, including body weight, body mass index, hemoglobin A1c level, blood pressure, blood glucose level, serum lipid profile, and urinary albumin excretion level, will be assessed at baseline and at 8, 16, and 24?weeks.

Discussion

The results of this RCT have the potential to provide a simple and novel clinical approach to reduce salt intake among patients with type 2 diabetes, making regular visits to their physician, in outpatient facilities. This protocol will contribute to the literature because it describes a practical intervention that has not been tested previously, and it may serve as guidance to other researchers interested in testing similar interventions.

Trial registration

University Hospital Medical Information Network (UMIN), UMIN000028809. Registered retrospectively on 24 August 2017. http://www.umin.ac.jp.

SUBMITTER: Ushigome E

PROVIDER: S-EPMC6929491 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Publications

Evaluation of the efficacy of simplified nutritional instructions from physicians on dietary salt restriction for patients with type 2 diabetes mellitus consuming excessive salt: protocol for a randomized controlled trial.

Ushigome Emi E Oyabu Chikako C Shiraishi Makoto M Kitagawa Nobuko N Kitae Aya A Iwai Keiko K Ushigome Hidetaka H Yokota Isao I Hamaguchi Masahide M Yamazaki Masahiro M Fukui Michiaki M

Trials 20191223 1

<h4>Background</h4>Hypertension is present in more than 50% of patients with type 2 diabetes mellitus. Dietary salt restriction is recommended for the management of high blood pressure. Instructions on dietary salt restriction, provided by a dietitian, have been shown to help patients reduce their salt intake. However, appointments for the dietitians in hospitals are often already fully booked, making it difficult for patients to receive instructions on the same day as the outpatient clinic visi ...[more]

PMID: 31870424

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Project description:The aim of this study was to estimate the effects of dietary salt reduction on blood pressure (BP) in Chinese adults and the effects of China-specific cooking salt-reduction strategies (the use of salt substitutes and salt-restriction spoons). The PubMed and China National Knowledge Infrastructure databases were searched for studies satisfying the search criteria. Outcomes extracted from each included study were 24-h urinary sodium excretion, salt (sodium chloride) intake, and BP before and after dietary salt lowering. A random-effects meta-analysis was performed, and results were evaluated for evidence of publication bias and heterogeneity. Because most studies aggregated results for hypertensive and normotensive participants, estimates were made for hypertensive participants only and for hypertensive and normotensive participants combined. Six salt-restriction experiment studies (3,153 participants), 4 cooking salt-restriction spoon studies (3,715 participants), and 4 cooking salt-substitute studies (1,730 participants) were analyzed. In salt-restriction experiment studies, the pooled estimate of mean change in 24-h urinary sodium excretion in hypertensive participants was -163.0 mmol/day (95% confidence interval [CI]: -233.5 to -92.5 mmol/day), which was associated with a mean reduction of -8.9 mm Hg (95% CI: -14.1 to -3.7 mm Hg) in systolic BP. Each 1.00-g dietary salt reduction in hypertensive participants was associated with a reduction of 0.94 mm Hg in systolic BP (95% CI: 0.69 to 1.03 mm Hg). These systolic BP reductions in hypertensive participants were 1.71 times greater compared with the mixed hypertensive and normotensive group. Salt-restriction spoon studies demonstrated a 1.46-g decrease in daily salt intake level. The effect of salt-substitute use on systolic BP control was substantial among the hypertensive participants (-4.2 mm Hg; 95% CI: -7.0 to -1.3 mm Hg), but the change did not reach statistical significance in hypertensive and normotensive participants combined (-2.31 mm Hg; 95% CI: -5.57 to 0.94 mm Hg). Salt restriction lowers mean BP in Chinese adults, with the strongest effect among hypertensive participants. Future studies of salt-restriction strategies should be report results stratified by hypertension status and adjust for medication use.

Project description:There are few studies on the mechanism of redox status imbalance and intestinal dysfunction in intrauterine growth restricted (IUGR) newborn piglets. Here, we investigated the mechanism of jejunum dysfunction in weaned piglets with IUGR and the mechanism through which dimethylglycine sodium salt (DMG-Na) supplementation improving the imbalance of their redox status. In this work, a total of 10 normal birth weight (NBW) newborn piglets and 20 IUGR newborn piglets were obtained. After weaning at 21 d, they were assigned to 3 groups (n = 10/group): NBW weaned piglets fed standard basal diets (NBWC); one IUGR weaned piglets fed standard basal diets (IUGRC); another IUGR weaned piglets from the same litter fed standard basal diets plus 0.1% DMG-Na (IUGRD). The piglets in these 3 groups were sacrificed at 49 d of age, and the blood and jejunum samples were collected immediately. The growth performance values in the IUGRC group were lower (P < 0.05) than those in the NBWC group. Jejunum histomorphological parameters, inflammatory cytokines, and digestive enzyme activity as well as serum immunoglobulin were lower (P < 0.05) in the IUGRC group than those in the NBWC group. Compared with these in the NBWC group, the redox status of serum, jejunum, and mitochondria and the expression levels of jejunum redox status-related, cell adhesion-related, and mitochondrial function-related genes and proteins were suppressed in the IUGRC group (P < 0.05). However, compared with those in the IUGRC group, the growth performance values, jejunum histomorphological parameters, inflammatory cytokines, digestive enzyme activity, serum immunoglobulin, redox status of serum, jejunum, and mitochondria, and the expression levels of jejunum redox status-related, cell adhesion-related, and mitochondrial function-related genes and proteins were improved (P < 0.05) in the IUGRD group. In conclusion, dietary DMG-Na supplementation alleviates redox status imbalance and intestinal dysfunction in IUGR weaned piglets mainly by activating the sirtuin 1 (SIRT1)/peroxisome proliferator-activated receptorγcoactivator-1α (PGC1α) pathway, thereby improving their unfavorable body state.

Dataset Information

Evaluation of the efficacy of simplified nutritional instructions from physicians on dietary salt restriction for patients with type 2 diabetes mellitus consuming excessive salt: protocol for a randomized controlled trial.

Background

Aim

Methods

Discussion

Trial registration

Publications

Evaluation of the efficacy of simplified nutritional instructions from physicians on dietary salt restriction for patients with type 2 diabetes mellitus consuming excessive salt: protocol for a randomized controlled trial.

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