scholarly journals Brief formula low‐energy‐diet for relapse management during weight loss maintenance in the Diabetes Remission Clinical Trial (DiRECT)

Author(s):  
Naomi Brosnahan ◽  
Wilma Leslie ◽  
Louise McCombie ◽  
Alison Barnes ◽  
George Thom ◽  
...  
Diabetologia ◽  
2021 ◽  
Author(s):  
Wilma S. Leslie ◽  
Eman Ali ◽  
Leanne Harris ◽  
C. Martina Messow ◽  
Naomi T. Brosnahan ◽  
...  

Abstract Aims/hypothesis Our aim was to evaluate the safety and efficacy of a planned therapeutic withdrawal of all antihypertensive and diuretic medications, on commencing a formula low-energy diet replacement, targeting remission of type 2 diabetes. Methods Post hoc analysis of changes in BP, antihypertensive medication prescriptions and symptoms during the initial total diet replacement phase was performed in the intervention arm of the Diabetes Remission Clinical Trial (n = 143) and in the subset (n = 69) who discontinued antihypertensive medications at the start of total diet replacement. The Counterweight-Plus total diet replacement provided about 3470 kJ/day (830 kcal) with automatic reductions in all nutrients, including sodium, to achieve marked negative energy balance and rapid weight loss over 12–20 weeks, with regular BP monitoring and an antihypertensive reintroduction protocol based on current clinical guidelines. Results Of 143 intervention group participants who commenced total diet replacement, 78 (55%) were on treatment for hypertension at baseline. The overall mean BP fell significantly from the start of total diet replacement (week 1) and was significantly lower at week 20, after total diet replacement finished, and also at 12 and 24 months. Of the 78 participants previously on treatment for hypertension, 65 (83%) stopped all antihypertensive and diuretic medications as per protocol, and four (5%) stopped some drugs. These 69 participants experienced no immediate (within the first week) change in BP, but their mean BP fell significantly from 9 weeks. No excessive rises in BP were recorded in individuals, but antihypertensive medications were reintroduced during total diet replacement to manage raised BP for 19/69 (27.5%) participants, mostly within the first 3–7 weeks, despite some weight loss. Reintroduction of antihypertensive medications was necessary for 5/19 participants previously on one drug, and for 14/19 previously on two or more drugs. Of the 69 who stopped antihypertensives, 19 (28%) remained off medications at 24 months. Among the 53 participants who achieved sustained remissions of diabetes at 24 months (with a mean weight loss of 11.4 kg), 31 had been previously treated for hypertension. Twenty-seven stopped medication at baseline, and 15/27 required reintroduction of antihypertensive medications. Mild to moderate dizziness, suggesting some postural hypotension, was reported during total diet replacement by 51 participants, 15 of whom had recorded dizziness at baseline prior to starting total diet replacement, with nine of these on antihypertensive or diuretic medications. Conclusions/interpretation Replacing antihypertensive medications with a 3470 kJ/day (830 kcal) diet to induce weight loss reduces BP substantially and may increase mild dizziness. It is safe to stop antihypertensives, but BP should be monitored regularly, particularly for those taking two or more antihypertensives, as over two-thirds will require reintroduction of some medications. Long-term support to maintain weight loss is vital. Trial registration ISRCTN registry, number 03267836. Graphical abstract


2019 ◽  
Vol 3 (Supplement_1) ◽  
Author(s):  
Zhanxuan Wu ◽  
Karl Fraser ◽  
Marlena Kruger ◽  
Garth Cooper ◽  
Anne-Thea McGill ◽  
...  

Abstract Objectives Plasma levels of branched-chain amino acids (BCAA) and aromatic amino acids (AAA) phenylalanine (phe) and tyrosine (tyr) have been associated with obesity, insulin resistance and risk of type 2 diabetes. This study aimed to investigate the response of circulating plasma and tissue levels of BCAA and AAA to weight loss, and to correlate the level of these metabolites in plasma and tissue in obese women. Methods 28 obese (mean BMI 46.2 kg/m2) women underwent low energy diet (LED)-induced weight loss (−9.2 ± 4.2 kg) followed by bariatric surgery-induced weight loss (−23.6 ± 2.5 kg). Plasma at baseline (t0), post-LED/pre-surgery (t1) and 6-month post-surgery (t2) as well as biopsies of subcutaneous abdomen adipose tissue (SAfat), superficial thigh adipose tissue (Tfat) and vastus lateralis thigh muscle (Tmuscle) at both t1 and t2 were collected, and profiled using mass spectrometry-based metabolomics approach. Paired t-tests were applied to assess between-timepoint differences, and Pearson correlation used to calculate correlation coefficient of metabolite levels between plasma and tissue. Results Plasma BCAA and AAA were all significantly reduced post-LED at t1 (fold-change of 0.76–0.85 for val, leu, ile, tyr and phe, P < 0.05) and 6-month post-surgery at t2 (fold-change of 0.74–0.85 for val, leu, ile, tyr and phe, P < 0.05) as compared to baseline t0; but not significant between t1 and t2, although trends of decrease were observed. Among the 3 tissue biopsies, only SAfat showed significantly decreased levels of tyr, leu and ile at t2 compared to t1 (fold-change for tyr 0.63, leu 0.66, ile 0.68, P < 0.05). In addition, plasma levels of val and ile were correlated with Tfat levels at both t1 and t2 (r2 = 0.47–0.57), and that of val, ile and leu were correlated with Tmuscle at t1 only (r2 = 0.64–0.67). Conclusions Circulating levels of BCAA and AAA were decreased by weight loss interventions. The decrease following an LED program was sustained after bariatric surgery without further significant decrease. Bariatric surgery also decreased BCAA levels in SAfat; moreover, our data suggested that plasma BCAA levels correlated well with peripheral tissue Tfat and Tmuscle. Funding Sources The New Zealand National Science Challenge High-Value Nutrition program.


2012 ◽  
Vol 108 (8) ◽  
pp. 1466-1474 ◽  
Author(s):  
Irene A. Munro ◽  
Manohar L. Garg

Obesity is associated with elevated levels of inflammation and metabolic abnormalities which are linked to CVD. The aim of the present study was to investigate whether long-chain n-3 PUFA (LCn-3PUFA), combined with a very-low-energy diet (VLED), facilitated weight loss and weight maintenance, and improvements in blood lipids and inflammatory mediators. This was a double-blind, randomised, controlled trial with two parallel groups. For 14 weeks, one group consumed 6 × 1 g capsules/d of monounsaturated oil (placebo group, PB), and the other group consumed 6 × 1 g capsules/d of LCn-3PUFA (fish oil group, FO), each comprising 70 mg EPA and 270 mg DHA. Both groups were on VLED for 4 weeks (n 14 PB, n 18 FO), which was then followed by 10 weeks of weight maintenance (n 12 PB, n 17 FO). Fasting blood samples, anthropometric measurements and 3 d food diaries were collected at baseline, at 4 and 14 weeks. A greater-than-2-fold increase occurred in plasma levels of EPA and DHA in the FO group (P < 0·001). At 4 weeks, the mean weight loss was − 6·54 (sd 2·08) kg ( − 6·9 %) for PB and − 6·87 (sd 1·83) kg ( − 7·7 %) for FO. At week 14, after the maintenance phase, there was a further mean decrease in weight, − 1·57 (sd 3·7) kg (1·85 %) for PB and − 1·69 (sd 2·32) kg ( − 1·9 %) for FO. Both groups experienced improved metabolic profiles and there was a significant reduction in fat mass for the FO group at week 14 but not for PB. However, it would appear that supplementation with LCn-3PUFA had no significant effect on weight loss or weight maintenance over the 14 weeks.


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