Short-term safety, tolerability and efficacy of a very low-calorie-ketogenic diet interventional weight loss program versus hypocaloric diet in patients with type 2 diabetes mellitus

Abstract

Brackground:The safety and tolerability of very low-calorie-ketogenic (VLCK) diets are a current concern in the treatment of obese type 2 diabetes mellitus (T2DM) patients.Objective:Evaluating the short-term safety and tolerability of a VLCK diet (<50 g of carbohydrate daily) in an interventional weight loss program including lifestyle and behavioral modification support (Diaprokal Method) in subjects with T2DM.Methods:Eighty-nine men and women, aged between 30 and 65 years, with T2DM and body mass index between 30 and 35 kg m−2 participated in this prospective, open-label, multi-centric randomized clinical trial with a duration of 4 months. Forty-five subjects were randomly assigned to the interventional weight loss (VLCK diet), and 44 to the standard low-calorie diet.Results:No significant differences in the laboratory safety parameters were found between the two study groups. Changes in the urine albumin-to-creatinine ratio in VLCK diet were not significant and were comparable to control group. Creatinine and blood urea nitrogen did not change significantly relative to baseline nor between groups. Weight loss and reduction in waist circumference in the VLCK diet group were significantly larger than in control subjects (both P<0.001). The decline in HbA1c and glycemic control was larger in the VLCK diet group (P<0.05). No serious adverse events were reported and mild AE in the VLCK diet group declined at last follow-up.Conclusions:The interventional weight loss program based on a VLCK diet is most effective in reducing body weight and improvement of glycemic control than a standard hypocaloric diet with safety and good tolerance for T2DM patients.

An evidence‐based approach to developing low‐carbohydrate diets for type 2 diabetes management: A systematic review of interventions and methods

“…Thirty‐one studies (31/40) reported a total energy prescription, of which 18/31 encouraged an ad libitum intake, 6/31 were moderately energy‐restricted (defined as any set caloric prescription >800 kcal/d that was not weight‐maintaining), 2/31 were severely energy‐restricted (defined as any set caloric prescription ≤800 kcal/d), and 5/31 were adaptive (defined as any caloric prescription that was adjusted according to individual participant progress or diet stage; Table and Table S5). For example, Goday et al used a hypocaloric “active phase” (600‐800 kcal/d) until adequate weight loss was achieved, then progressively increased CHO and energy during a “maintenance stage”. Two other studies using adaptive energy prescriptions were weight‐maintaining by design .…”

“…Of these, 15/29 used high‐frequency contact (defined as ≥2 sessions/month), 10/29 used moderate‐frequency contact (defined as ≥1 session/month), and 4/29 used low‐frequency contact (defined as <1 session/month). Five (5/40) studies reported the use of remote contact (eg, email, phone, web‐based application, online discussion boards) for the majority or all of the scheduled contact, or as a supplement to in‐person contact . One study offered participants a choice between remote and/or in‐person contact …”

“…It appears that no one single CHO amount for T2D is effective, yet there is growing interest in using more pronounced CHO restriction for at least part of the intervention duration. Very‐low‐CHO diet protocols (0‐50 g/d) tended to be described as ketogenic diets and/or set goals to achieve nutritional ketosis as measured by blood ketones . Proposed benefits of nutritional ketosis for T2D include decreased circulating glucose and insulin and increased ketone signalling, which may provide protection against oxidative stress .…”

4. Lifestyle Management:Standards of Medical Care in Diabetes—2018

“…While benefits to low-carbohydrate diets have been described, improvements tend to be in the short term and, over time, these effects are not maintained (74)(75)(76)(77). While some studies have shown modest benefits of very low-carbohydrate or ketogenic diets (less than 50-g carbohydrate per day) (78,79), this approach may only be appropriate for short-term implementation (up to 3-4 months) if desired by the patient, as there is little longterm research citing benefits or harm.…”

ISPAD Clinical Practice Consensus Guidelines 2018: Nutritional management in children and adolescents with diabetes

“…This may be helpful in reducing the need for snacks and large meals. Medical nutrition therapy should be provided to treat co‐morbidities including obesity, dyslipidemia, hypertension and microvascular complications . Regular follow‐up is essential to monitor weight, glycemic control and adherence to the meal plan. Very low‐calorie‐ketogenic (VLCK) diets can be safely and effectively used in the management of young adults with type 2 diabetes . Clinical experience suggests obese older adolescents with type 2 diabetes may also benefit from a carefully monitored VLCK weight loss program.…”