Association of Inadequate Health Literacy with Health Outcomes in Patients with Type 2 Diabetes and Depression: Secondary Analysis of a Controlled Trial

Background Beyond antihyperglycemic effects, metformin may improve cardiovascular outcomes. Patients with type 2 diabetes often have an elevated plasma level of N-terminal pro B-type as a marker of (sub) clinical cardiovascular disease. We studied whether metformin was associated with a reduction in the serum level of N-terminal pro B-type natriuretic peptide (NT-proBNP) in these patients. Methods In the HOME trial 390 insulin-treated patients with type 2 diabetes were randomized to 850 mg metformin or placebo three times daily. Plasma samples were drawn at baseline, 4, 17, 30, 43 and 52 months. In a post-hoc analysis we analyzed the change in NT-proBNP in both groups. We used a longitudinal mixed model analysis adjusting for age, sex and prior cardiovascular disease. In a secondary analysis we assessed a possible immediate treatment effect post baseline. Results Metformin did not affect NT-proBNP levels over time in the primary analysis (-1% [95%CI -4;3, p = 0.62]). In the secondary analysis there was also no sustained time independent immediate treatment effect (initial increase of 17% [95%CI 4;30, p = 0.006] followed by yearly decrease of -4% [95%CI -7;0, p = 0.07]). Conclusions Metformin as compared to placebo did not affect NT-proBNP plasma levels in this 4.3-year placebo-controlled trial. Potential cardioprotective effects of metformin cannot be explained by changes in cardiac pressures or volumes to the extent reflected by NT-proBNP.

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Nutritional adequacy of very low- and high-carbohydrate, low saturated fat diets in adults with type 2 diabetes: A secondary analysis of a 2-year randomised controlled trial

Diabetes Research and Clinical Practice ◽

10.1016/j.diabres.2020.108501 ◽

2020 ◽

Vol 170 ◽

pp. 108501

Author(s):

Jeannie Tay ◽

Campbell H. Thompson ◽

Natalie D. Luscombe-Marsh ◽

Manny Noakes ◽

Jonathan D. Buckley ◽

...

Keyword(s):

Type 2 Diabetes ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Secondary Analysis ◽

Saturated Fat ◽

Nutritional Adequacy ◽

High Carbohydrate ◽

Randomised Controlled ◽

Fat Diets

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Eating self-efficacy changes in individuals with type 2 diabetes following a structured lifestyle intervention based on the transcultural Diabetes Nutrition Algorithm (tDNA): A secondary analysis of a randomized controlled trial

PLoS ONE ◽

10.1371/journal.pone.0242487 ◽

2020 ◽

Vol 15 (11) ◽

pp. e0242487

Author(s):

Harvinder Kaur Gilcharan Singh ◽

Winnie Siew Swee Chee ◽

Osama Hamdy ◽

Jeffrey Ian Mechanick ◽

Verna Kar Mun Lee ◽

...

Keyword(s):

Type 2 Diabetes ◽

Clinical Trial ◽

Weight Loss ◽

Motivational Interviewing ◽

Lifestyle Intervention ◽

Self Efficacy ◽

Controlled Trial ◽

Secondary Analysis ◽

Registration Number

Objective Eating self-efficacy behavior is an important predictor of successful lifestyle intervention. This secondary analysis evaluated the changes in eating self-efficacy behavior in patients with type 2 diabetes (T2D) and overweight/obesity following structured lifestyle intervention based on the Malaysian customized transcultural Diabetes Nutrition Algorithm (tDNA). Methods Patients with T2D and overweight/obesity (n = 230) were randomized either into the tDNA group which included a structured low-calorie meal plan using normal foods, incorporation of diabetes-specific meal replacements, and an exercise prescription or usual T2D care (UC) for 6 months. Patients in the tDNA group also received either counseling with motivational interviewing (tDNA-MI) or conventional counseling (tDNA-CC). The UC group received standard dietary and exercise advice using conventional counseling. Eating self-efficacy was assessed using a locally validated Weight Efficacy Lifestyle (WEL) questionnaire. All patients were followed up for additional 6 months’ post-intervention. Results There was a significant change in WEL scores with intervention over one-year [Group X Time effect: F = 51.4, df = (3.4, 318.7), p<0.001]. Compared to baseline, WEL scores improved in both the tDNA groups with significantly higher improvement in the tDNA-MI group compared to the tDNA-CC and UC groups at 6 months (tDNA-MI: 25.4±2.1 vs. tDNA-CC: 12.9±2.8 vs. UC: -6.9±1.9, p<0.001). At 12 months’ follow-up, both the tDNA groups maintained improvement in the WEL scores, with significantly higher scores in the tDNA-MI group than tDNA-CC group, and the UC group had decreased WEL scores (tDNA-MI: 28.9±3.1 vs. tDNA-CC: 11.6±3.6 vs. UC: -13.2±2.1, p<0.001). Patients in the tDNA-MI group with greater weight loss and hemoglobin A1C reduction also had a higher eating self-efficacy, with a similar trend observed in comparative groups. Conclusion Eating self-efficacy improved in patients with T2D and overweight/obesity who maintained their weight loss and glycemic control following a structured lifestyle intervention based on the Malaysian customized tDNA and the improvement was further enhanced with motivational interviewing. Clinical trial This randomized clinical trial was registered under National Medical Research Registry, Ministry of Health Malaysia with registration number: NMRR-14-1042-19455 and also under ClinicalTrials.gov with registration number: NCT03881540.

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Dapagliflozin does not affect short-term blood pressure variability in patients with type-2 diabetes mellitus

American Journal of Hypertension ◽

10.1093/ajh/hpaa207 ◽

2020 ◽

Author(s):

Eirini Papadopoulou ◽

Marieta P Theodorakopoulou ◽

Charalampos Loutradis ◽

Georgios Tzanis ◽

Glykeria Tzatzagou ◽

...

Keyword(s):

Diabetes Mellitus ◽

Blood Pressure ◽

Type 2 Diabetes ◽

Type 2 Diabetes Mellitus ◽

Blood Pressure Variability ◽

Controlled Trial ◽

Secondary Analysis ◽

Short Term ◽

Double Blind

Abstract Background Increased blood-pressure-variability (BPV) is associated with increased cardiovascular and all-cause mortality in patients with type 2 diabetes mellitus (T2DM). Sodium-glucose-co-transporter-2 (SGLT-2) inhibitors decrease the incidence of cardiovascular events, renal events, and death in this population. This study aimed to evaluate the effect of dapagliflozin on short-term BPV in patients with T2DM. Methods This is a secondary analysis of a double-blind, randomized, placebo-controlled trial in 85 patients with T2DM (NCT02887677). Subjects were randomized to oral dapagliflozin 10mg once daily or placebo for 12 weeks. All participants underwent 24-h ambulatory blood pressure (BP) monitoring with the Mobil-O-Graph NG device at baseline and study-end. Standard-deviation (SD), weighted-SD (wSD), coefficient-of-variation (CV), average-real-variability (ARV) and variation-independent-of-mean (VIM) were calculated with validated formulae for the 24-h and the daytime and nighttime periods. Results Dapagliflozin reduced 24-h brachial BP compared to placebo. From baseline to study-end 24-h brachial BPV indexes did not change with dapagliflozin (SBP-ARV: 11.51±3.45 vs 11.05±3.35; p=0.326, SBP-wSD: 13.59±3.60 vs 13.48±3.33; p=0.811) or placebo (SBP-ARV: 11.47±3.63 vs 11.05±3.00; p=0.388, SBP-wSD: 13.85±4.38 vs 13.97±3.87 ; p=0.308). Similarly, no significant changes in BPV indexes for daytime and nighttime were observed in any group. At study-end, no differences between the groups were observed for any BPV index. Deltas(Δ) of all indexes during follow-up were minimal and not different between-groups (SBP-wSD: dapagliflozin: -0.11±3.05 vs placebo: 0.12±4.20; p=0.227). Conclusions This study is the first to evaluate the effects of an SGLT-2 inhibitor on short-term BPV in patients with T2DM, showing no effect on dapagliflozin on all BPV indexes studied.

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