The Metabolic Impact of Intermittent Carbohydrate Restriction in Individuals With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- 24-hour average sensor glucose
研究概览
简要总结
The primary aim of this randomized cross-over intervention study is to investigate the effect of four weeks of intermittent carbohydrate restriction (alternating between two days of normal dietary intake and two days of carbohydrate restriction to 70-90 grams) on 24-hour average sensor glucose in individuals with type 2 diabetes compared with a four-week control period with normal dietary intake.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women
- •35-75 years old
- •BMI >27 kg/m2
- •Known type 2 diabetes in stable glucose lowering therapy (for three months) or with HbA1c >48 mmol/mol if no glucose lowering therapy
排除标准
- •Anemia (hemoglobin <8 mmol/L for men and <7 mmol/L for women)
- •TSH outside reference range
- •Treatment with insulin, sulfonylurea, or SGLT2-inhibitors
- •Treatment with systemic corticosteroids
- •HbA1c >70 mmol/mol
- •eGFR <60 ml/min/1.73 m2
- •Contraindications for MR-scan: abdominal height exceed limitations of the MR-scanner, pacemaker or other electronic device implanted, implanted metal devices, severe claustrophobia
- •Food allergies (including lactose and gluten intolerance)
- •Vegetarian/vegan diet or following of specific dietary plans
- •Alcohol consumptions >84/168 g/week (women/men)
- •Strenuous activity level > 120 minutes per week
- •Weight loss (>5 kg) within the last three months or previous bariatric surgery
- •High risk of fibrosis of the liver (estimated by FIB4 score > 3.25)
研究组 & 干预措施
Intermittent carbohydrate restriction
Four weeks of intermittent carbohydrate restriction: a dietary regime alternating between two days of restricting carbohydrate intake to 70-90 grams, while energy intake is ad libitum, from fat- and protein-containing foods, and two days of non-restricted diet.
干预措施: Dietary macronutrient composition (Other)
Control arm
Four weeks of free-living with no dietary restrictions.
结局指标
主要结局
24-hour average sensor glucose
时间窗: 24-hour average sensor glucose is measured as the average of eight consecutive days (starting from two days post sensor mounting) from the intermittent carbohydrate restriction period and the corresponding days of the control period (i.e. days 17-24).
A patient-blinded continuous glucose monitoring (CGM) is worn during the last two weeks of both the intervention and control period.
次要结局
- Liver triacylglycerol content(day 30 adjusted for baseline)
- Fasting plasma concentrations of triacylglycerols(day 30 adjusted for baseline)
研究者
Kirstine Nyvold Bojsen-Moeller
MD, PhD, Associate Professor
Hvidovre University Hospital