To Lower Glucose Levels and Reduce Weight by Exclusion of Carbohydrates and Inclusion of Psychological Behavioral Support
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Long-term glucose levels
研究概览
简要总结
Risk-patients for diabetes or patients that are diagnosed with this condition but who are not treated with insulin are randomized two times, according to diet and according to the type of support:
Randomization with regard to carbohydrate restriction (25-30 E% or < 10E%). Randomization with regard to type of psychological support. Either according to Acceptance and Commitment Therapy or to traditional cognitive behavioral therapy. Both kinds of psychological support is given as group therapy.
Two-hundred patients are recruited and each patient is followed for two years.
详细描述
The organizers will recruit 200 patients in the study "To lower glucose levels and reduce weight by exclusion of carbohydrates and inclusion of psychological behavioral support" (LOWinCHIP) at the primary care health center "Cithyhälsan Centrum" in Norrköping. Each patient will be followed for 2 years. Patients are eligible if they have are above 18 years of age and have a BMI above 28 kg/m2 and also belong to one or more of the following groups: 1) type 2 diabetes that is not treated with insulin. 2) Patients that have had gestational diabetes or who have 3) first grade relative with type 2 diabetes. Finally 4) pre-diabetic individuals with impaired fasting glucose (6.1-6.9 mmol) or impaired glucose tolerance (capillary plasma glucose 8.9-12-1 after glucose challenge) are also potential participants. Patients must not have insulin therapy or severe kidney failure (GFR< 30). They can also not have severe physical restrictions for activity and they must not have difficulties with understanding written Swedish texts.
The participants are randomized two times (two by two factorial):
Randomization with regard to carbohydrate restriction (25-30 E% or < 10E%). Randomization with regard to type of psychological support. Either according to Acceptance and Commitment Therapy (ACT) or to traditional cognitive behavioral therapy. Each group will have three group sessions with approximately 8 participants followed by a telephone call by the therapist. Each session will be held by the psychologists that are part of the Cityhälsan Centrum staff.
The study has > 95% power to demonstrate 5% HbA1c (mmol/mol) difference between groups with a drop out of 25%.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes without insulin. Patients at high risk for developing diabetes.
排除标准
- •Severe kidney failure. Insulin therapy. Inability to understand instructions.
研究组 & 干预措施
Moderate carbohydrate restriction and traditional support
Moderate carbohydrate restriction and traditional support with group meetings
干预措施: Diet regime (Behavioral)
Moderate carbohydrate restriction and traditional support
Moderate carbohydrate restriction and traditional support with group meetings
干预措施: Type of psychological support (Behavioral)
Extreme low carbohydrate diet and traditional support
Extreme carbohydrate restriction and traditional support with group meetings
干预措施: Diet regime (Behavioral)
Extreme low carbohydrate diet and traditional support
Extreme carbohydrate restriction and traditional support with group meetings
干预措施: Type of psychological support (Behavioral)
Moderate carbohydrate restriction and ACT support
Moderate carbohydrate restriction and psychological support based on acceptance and commitment therapy
干预措施: Diet regime (Behavioral)
Moderate carbohydrate restriction and ACT support
Moderate carbohydrate restriction and psychological support based on acceptance and commitment therapy
干预措施: Type of psychological support (Behavioral)
Extreme carbohydrate restriction and ACT support
Extreme carbohydrate restriction and psychological support based on acceptance and commitment therapy
干预措施: Diet regime (Behavioral)
Extreme carbohydrate restriction and ACT support
Extreme carbohydrate restriction and psychological support based on acceptance and commitment therapy
干预措施: Type of psychological support (Behavioral)
结局指标
主要结局
Long-term glucose levels
时间窗: 2 years
HbA1c levels
次要结局
- Cardiovascular risk factors(2 years)
- Quality of Life(2 years)
研究者
Fredrik H Nystrom
Professor, head of Internal Medicine, consultant in Endocrinology.
University Hospital, Linkoeping
