1. |
- Bolinder, Jan, et al.
(author)
-
Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin
- 2012
-
In: Journal of Clinical Endocrinology and Metabolism. - : The Endocrine Society. - 0021-972X .- 1945-7197. ; 97:3, s. 1020-1031
-
Journal article (peer-reviewed)abstract
- Context:Dapagliflozin, a selective sodium-glucose cotransporter 2 (SGLT2) inhibitor, reduces hyperglycemia in patients with type 2 diabetes mellitus (T2DM) by increasing urinary glucose excretion, and weight loss is a consistent associated finding.Objectives:Our objectives were to confirm weight loss with dapagliflozin and establish through body composition measurements whether weight loss is accounted for by changes in fat or fluid components.Design and Setting:This was a 24-wk, international, multicenter, randomized, parallel-group, double-blind, placebo-controlled study with ongoing 78-wk site- and patient-blinded extension period at 40 sites in five countries.Patients:Included were 182 patients with T2DM (mean values: women 63.3 and men 58.6 yr of age; hemoglobin A1c 7.17%, body mass index 31.9 kg/m2, and body weight 91.5 kg) inadequately controlled on metformin.Intervention:Dapagliflozin 10 mg/d or placebo was added to open-label metformin for 24 wk.Main Outcome Measures:Primary endpoint was total body weight (TBW) change from baseline at wk 24. Key secondary endpoints were waist circumference and dual-energy x-ray absorptiometry total-body fat mass (FM) changes from baseline at wk 24, and patient proportion achieving body weight reduction of at least 5% at wk 24. In a subset of patients, magnetic resonance assessment of visceral adipose tissue (VAT) and sc adipose tissue (SAT) volume and hepatic lipid content were also evaluated.Results:At wk 24, placebo-corrected changes with dapagliflozin were as follows: TBW, −2.08 kg [95% confidence interval (CI) = −2.84 to −1.31; P < 0.0001]; waist circumference, −1.52 cm (95% CI = −2.74 to −0.31; P = 0.0143); FM, −1.48 kg (95% CI = −2.22 to −0.74; P = 0.0001); proportion of patients achieving weight reduction of at least 5%, +26.2% (95% CI = 15.5 to 36.7; P < 0.0001); VAT, −258.4 cm3 (95% CI = −448.1 to −68.6; nominal P = 0.0084); SAT, −184.9 cm3 (95% CI = −359.7 to −10.1; nominal P = 0.0385). In the dapagliflozin vs. placebo groups, respectively, serious adverse events were reported in 6.6 vs. 1.1%; events suggestive of vulvovaginitis, balanitis, and related genital infection in 3.3 vs. 0%; and lower urinary tract infections in 6.6 vs. 2.2%.Conclusions:Dapagliflozin reduces TBW, predominantly by reducing FM, VAT and SAT in T2DM inadequately controlled with metformin.
|
|
2. |
- Scheers, Nathalie, 1974, et al.
(author)
-
Vitamin B12 as a potential compliance marker for fish intake
- 2014
-
In: European Journal of Nutrition. - : Springer Science and Business Media LLC. - 1436-6207 .- 1436-6215. ; 53:6, s. 1327-1333
-
Journal article (peer-reviewed)abstract
- Objectives: The aim of the present study was to investigate whether the following four markers; Vitamin B12, selenium, vitamin D, and parvalbumin may be used as compliance markers for fish intake. Methods: Blood samples from a randomized cross-over herring intervention study (n=32) were analyzed by HPLC and immunochemistry. The criteria were that plasma or serum concentrations of candidate compliance markers after the herring diet should increase significantly compared to starting concentrations. In addition, the reference meat diet should not yield an increase in plasma concentration of the candidate marker. Results: Vitamin B12 and selenium met the set criteria for indicating a correlation between the marker and fish intake with significant increases in serum concentrations at 8.9% (p=0.008) and 4.6% (p=0.02) respectively after a 6-week herring intervention (5 meals a week). Parvalbumin and 25-hydroxy vitamin D3 levels did not increase significantly during the herring interventions. Conclusions: Vitamin B12 may be suitable as a compliance marker for fish intake. Although selenium also met the criteria, the change in selenium serum concentrations was small compared to the change in vitamin B12 levels.
|
|