Effects of Protein-Sparing Modified Fasting on Obese Japanese Patients

Saitō, Yasushi; Ishikawa, Yudai; Shinomiya, Masaki; Shirai, Kohji; Yoshida, Sho

doi:10.3164/jcbn.2.91

Cited by 5 publications

(2 citation statements)

References 15 publications

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“…To conduct a double-blind, randomized, controlled trial comparing diets with identical calories and carbohydrate ratio, we used FD. Formula diet contains low carbohydrate, low fat, and sufficient protein, vitamins and minerals to support a healthy and balanced diet, and was originally developed for treating severe obesity as a low-calorie food 37 – 40 . Dapagliflozin was used as the SGLT2i.…”

Section: Methodsmentioning

confidence: 99%

A randomized controlled trial of two diets enriched with protein or fat in patients with type 2 diabetes treated with dapagliflozin

Watanabe

Suzuki

Kuribayashi³

et al. 2021

Sci Rep

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Sodium-glucose cotranspsorter-2 (SGLT2) inhibitors (SGLT2i) involve loss of skeletal muscle mass, potentially leading to inadequate HbA1c reduction in type 2 diabetes (T2DM), since muscle mass is related to insulin sensitivity. The benefit of protein-enriched diet for improving HbA1c in SGLT2i-treated T2DM patients remains unclear. We conducted a multicenter, double-blind, randomized, controlled, investigator-initiated clinical trial. 130 T2DM patients treated with dapagliflozin (5 mg) were randomized to isoenergic protein-rich formula diet (P-FD) or fat-rich FD (F-FD) (1:1 allocation) to replace one of three meals/day for 24 weeks. Primary outcome was change in HbA1c. Secondary outcomes were changes in serum insulin, body composition and other metabolic parameters. Although HbA1c decreased significantly in both groups [mean (95% confidence interval) − 0.7% (− 0.9 to − 0.5) in P-FD, − 0.6% (− 0.8 to − 0.5) in F-FD], change in HbA1c was not significantly different between the two groups (P = 0.4474). Fasting insulin and body fat mass decreased, while HDL-cholesterol increased significantly in P-FD, and these changes were significantly greater compared with F-FD (all, P < 0.05). In T2DM treated with dapagliflozin, protein-enriched diet does not contribute to HbA1c reduction, although it decreases serum insulin and body fat mass, and increases HDL-cholesterol compared with fat-enriched diet with identical calories and carbohydrate ratio.

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Section: Methodsmentioning

confidence: 99%

A randomized controlled trial of two diets enriched with protein or fat in patients with type 2 diabetes treated with dapagliflozin

Watanabe

Suzuki

Kuribayashi³

et al. 2021

Sci Rep

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show abstract

“…Successful lifestyle intervention results in good glycemic control by improving insulin activity and pancreatic -cell response to insulin secretory stimuli 11,12) . Thus, in combination with lifestyle intervention, switching from SUs to glinides is likely to be feasible, and SUs might be unnecessary in these patients.…”

mentioning

confidence: 99%

Treatment with Glimepiride, but not Mitiglinide and Short-Acting Insulin, Resists Body Weight and Abdominal Fat Reduction Under Dietary Energy Restriction

Nakano

Inoue

Satoh

et al. 2009

JAT

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Study Protocol for the Effects of Formula Diet with Dapagliflozin on Metabolic Improvement and Body Composition in Type 2 Diabetes Mellitus

Watanabe

Kuribayashi²,

Uchida

et al. 2018

Diabetes Ther

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IntroductionSodium-dependent glucose transporter-2 (SGLT2) inhibitors such as dapagliflozin induce weight loss, but the mechanism is thought to involve loss of both body fat and skeletal muscle mass. The decrease in skeletal muscle mass may lead to worsening of insulin resistance in type 2 diabetes patients. On the other hand, formula diet (FD) is a low-calorie food containing low carbohydrates, low fat, and sufficient protein, vitamins, and minerals to support a healthy and balanced diet, and is used for the treatment of obesity or diabetes. Therefore, we examine whether the protein supplementation is superior to the fat supplementation in metabolic improvement of the poorly controlled type 2 diabetes patients treated with SGLT2 inhibitor. We compare the therapeutic effects using two types of FD; a high protein FD and a high fat FD. Patients are prescribed dapagliflozin and replacement of one of three meals with FD. We compare high protein FD and high fat FD with respect to improvement of glycemic control while maintaining skeletal muscle mass.MethodsWe conduct a prospective, multicenter, double-blinded, randomized, controlled, investigator-initiated clinical trial. Patients who satisfy the eligibility criteria will be randomized to two groups (1:1) and prescribed 5 mg of dapagliflozin once daily together with a high protein FD or high fat FD (same number of calories) to replace one of three meals a day (one meal with FD only and two normal meals). The observation period for both groups is 24 weeks. The primary endpoint is the change in HbA1c.Planned OutcomesThis study is ongoing and scheduled to complete in June 2019. The findings of this study will be disseminated through peer-reviewed publications and conference presentations.Trial RegistrationUniversity Hospital Medical Information Network (UMIN) 000024580.FundingThis study was carried out under contract with the specified nonprofit corporation Hokkaido Institute of Health Sciences, based on a grant from AstraZeneca Co., Ltd. and Ono Pharmaceutical Co., Ltd. for an investigator-initiated clinical trial. The authors funded the journals article processing charges.

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Effects of Protein-Sparing Modified Fasting on Obese Japanese Patients

Cited by 5 publications

References 15 publications

A randomized controlled trial of two diets enriched with protein or fat in patients with type 2 diabetes treated with dapagliflozin

A randomized controlled trial of two diets enriched with protein or fat in patients with type 2 diabetes treated with dapagliflozin

Treatment with Glimepiride, but not Mitiglinide and Short-Acting Insulin, Resists Body Weight and Abdominal Fat Reduction Under Dietary Energy Restriction

Study Protocol for the Effects of Formula Diet with Dapagliflozin on Metabolic Improvement and Body Composition in Type 2 Diabetes Mellitus

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