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临床试验/NCT03090074
NCT03090074Unknown不适用

To Lower Glucose Levels and Reduce Weight by Exclusion of Carbohydrates and Inclusion of Psychological Behavioral Support

University Hospital, Linkoeping2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年3月20日最近更新:
适应症
干预措施

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

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

Active Comparator

Moderate carbohydrate restriction and traditional support with group meetings

干预措施: Diet regime (Behavioral)

Moderate carbohydrate restriction and traditional support

Active Comparator

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

Active Comparator

Extreme carbohydrate restriction and traditional support with group meetings

干预措施: Diet regime (Behavioral)

Extreme low carbohydrate diet and traditional support

Active Comparator

Extreme carbohydrate restriction and traditional support with group meetings

干预措施: Type of psychological support (Behavioral)

Moderate carbohydrate restriction and ACT support

Active Comparator

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

Active Comparator

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

Active Comparator

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

Active Comparator

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

发起方
University Hospital, Linkoeping
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fredrik H Nystrom

Professor, head of Internal Medicine, consultant in Endocrinology.

University Hospital, Linkoeping

研究点 (2)

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