Cut Down on Carbohydrate in the Dietary Therapy of Type 2 Diabetes Mellitus - The Meal Box Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in glycated hemoglobin (HbA1c) after 12 months on the CRHP diet compared with the CD diet
研究概览
简要总结
The cornerstone in the initial treatment of type 2 diabetes (T2D) is lifestyle modification, involving-among other things-a healthy diet. However, scientific evidence regarding optimal nutrition therapy for patients with T2D is insufficient.
This clinical study will examine the effect of a carbohydrate-reduced high-protein (CRHP) diet compared to a conventional diabetes (CD) diet for 12 months on metabolic function and body weight in patients with T2D.
The hypothesis of the study is that the CRHP diet will improve metabolic control and the cardiovascular risk profile of patients with T2D to a greater extent than the CD diet. In particular, the expectation is that, compared with the CD diet, the CRHP diet will:
- Reduce diurnal and postprandial glycemia measured by continuous glucose monitoring (CGM) and thereby facilitate a significant reduction of glycated hemoglobin (HbA1c)
- Reduce body weight
- Reduce ectopic fat deposition in the liver and the pancreas
- Improve the blood lipid profile
- Reduce or not affect blood pressure with no adverse effect on heart rate variability
- Increase insulin sensitivity and secretion
- Decrease inflammatory markers in the blood
- Improve satiety
- Reduce or not affect the need for antidiabetic, antihypertensive and/or lipid-lowering medications
To reinforce the results and knowledge generated from the primary study, participants will be invited to partake in a 12-month follow-up period after the initial 12 months of intervention.
详细描述
Methods: This is a 12-month investigator-initiated, randomized, controlled, open-label, superiority trial with two parallel groups. The study examines the effect of a CRHP diet (which is reduced in carbohydrate and increased in protein and fat) compared with a CD diet (which follows the currently recommended macronutrient intake for patients with T2D). The study will include 100 T2D patients with overweight or obesity.
The CD diet and CRHP diet comprise 50 percentage of energy (E%) and 30 E% from carbohydrate, 17 E% and 30 E% from protein, and 33 E% and 40 E% from fat, respectively. The CD diet and the CRHP diet do not principally differ in the quality of carbohydrate, protein, and fat; they both comprise of nutritious, organic, and sustainable food items.
Participants will be randomized in a 1:1 ratio to either the CD diet or the CRHP diet for 12 months. About 2/3 of the total calculated energy requirements on both diets will be delivered to the participants free of charge, as meal box solutions containing breakfast meals, snack meals, and dinner meals to optimize compliance and adherence to the assigned diet.
After 12 months of intervention with meal boxes, a 12-month follow-up period will be initiated for participants who wish to continue to follow the diet they were allocated to at baseline. During the 12-month follow-up period there will be no provision of meal boxes. Assistance is provided to help the participants adhere to the diet by regular counselling with RCD's and support via the Liva app.
The daily energy requirements for body weight maintenance will be calculated by multiplying resting energy expenditure using the Mifflin-St Jeor equation, with an estimated physical activity level (estimated by using a physical activity questionnaire at the beginning of the study). Based on the calculated daily energy requirements, participants will be divided into one of three energy level groups; in all groups, the amount of recommended total daily energy intake will exceed the amount required for weight maintenance and subjects will be instructed to consume the diets ad libitum until satiety is achieved.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
The endocrinologists responsible for the pharmacological regulations during the study will be blinded to the allocation of the participants.
In addition, the bio-analysts performing laboratory analyses, the MR physicist responsible for evaluating MRI/MRS scans, and the individual performing DXA scans, handgrip strength and 30-second chair-stand tests will also be blinded to the allocated diet group.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or postmenopausal women aged 18-75 years. Menopause is defined as >12 months without menses
- •Overweight or obesity with Body Mass Index (BMI) >25 kg/m2
- •Type 2 diabetes with HbA1c between 48 mmol/mol and 75 mmol/mol (6.5%-9.0%)
- •Treated with or without metformin, dipeptidyl peptidase 4 (DPP-4) inhibitors, sodium-glucose cotransporter 2 (SGLT-2) inhibitors and/or glucagon-like peptide 1 receptor agonists (GLP-1RA)
- •Nonsmokers or having quitted smoking >1 year before the study
- •Acceptance of regulation of antidiabetic, antihypertensive, and lipid-lowering medications by Cut-DM endocrinologists only
排除标准
- •Ongoing insulin or insulin analog therapy
- •Severe gut disease as evaluated by the principal investigator e.g. Crohn's disease, Ulcerative colitis, Celiac disease etc.
- •Extensive surgery to the gut e.g. bariatric surgery, colectomy etc.
- •Severe heart disease as evaluated by the principal investigator e.g. angina pectoris, coronary heart disease, congestive heart failure (NYHA III-IV)
- •Severe renal impairment (eGFR<45 ml/min/1.73 m2 or urine albumin / creatinine ratio > 300 mg/g)
- •Severe hepatic impairment as evaluated by the principal investigator (measure of alanine aminotransferase (ALT) and aspartate aminotransferase (AST))
- •Cancer within the last 5 years (except basal cell skin cancer or squamous cell skin cancer)
- •Psychiatric disease, e.g. a history of major depressive or other severe psychiatric disorders
- •Ongoing systemic corticosteroid treatment, e.g. prednisolone
- •Reported or documented food allergy, food intolerance, or currently following a particular eating pattern or strong food preferences, not compatible with study participation
- •Reported or documented alcohol consumption exceeding the recommendations from The Danish Health Authorities
- •Ongoing treatment with sulfonylureas and/or thiazolidinediones due to the risk of hypoglycemia unless discontinuation is possible, in which case a >3-month wash-out is mandatory
- •Hemoglobin <7 mmol/L for men and <6 mmol/L for women
- •Inability, physically and/or mentally, to comply with the procedures required by the study protocol, as evaluated by the principal investigator
- •Weight change ≥5% the preceding 3 months of screening
- •Participation in other on-going clinical trials
研究组 & 干预措施
Therapeutic Diet: CRHP Diet
Carbohydrate-reduced high-protein (CRHP) dietary intervention. Intervention: Therapeutic Diet: CRHP Diet.
干预措施: Carbohydrate-reduced high-protein (CRHP) Diet (Other)
Therapeutic Diet: CD Diet
Conventional diabetes (CD) dietary intervention. Intervention: Therapeutic Diet: CD Diet.
干预措施: Conventional diabetes (CD) Diet (Other)
结局指标
主要结局
Change in glycated hemoglobin (HbA1c) after 12 months on the CRHP diet compared with the CD diet
时间窗: Baseline, 3, 6, 9 and 12 months
HbA1c will be measured in fasting blood samples at baseline, 3, 6, 9 and 12 months. HbA1c will be expressed in mmol/mol.
次要结局
- Change in hepatic fat content after 12 months on the CRHP diet compared with the CD diet(Baseline and 12 months)
- Change in total body weight after 12 months on the CRHP diet compared with the CD diet(Baseline, 3, 6, 9 and 12 months)
研究者
Thure Krarup
MD, Professor, DMSc
Bispebjerg Hospital