跳至主要内容
临床试验/NCT03281616
NCT03281616已完成不适用

Lifestyle Interventions in Turkish-background Patients With Metabolic Syndrome and Diabetes in Germany

Charite University, Berlin, Germany0 个研究点目标入组 110 人开始时间: 2014年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
110
主要终点
Body weight reduction

研究概览

简要总结

Background: Life-style interventions are indicated in patients with metabolic syndrome and/or type 2 diabetes. However, cultural differences are substantial confounders to not only compliance, but also whether or not the interventions are offered in the first place. In Germany, the large Turkish-background minority has a particularly high incidence of type 2 diabetes, but there is no recorded evidence of a life-style intervention in this patient group.

Objective: The investigators tested the body weight-reducing effect of a 30% calorie-reduced diet, adjusted to individual eating habits and preferences regarding quality and resources of food in a Turkish-background cohort.

详细描述

The investigators conducted a prospective, randomized, two-arm parallel study. In both arms, patients were instructed in a 12-week diet that was reduced by in caloric content by at least 30% based on calorimetric measurements of 24 h resting energy expenditure and estimated additional expenditures by diet- and activity-induced thermogenesis. Before and after the diet, anthropometric measures and various MetS-associated blood parameters were determined.

The subjects were not instructed in an exercise program. However, the subjects were advised on the value of increased physical activity. For additional motivation, effects were tested by an activity monitor. Therefore, in one of the arms, 24 hour locomotor activity and energy expenditure were determined by means of the SenseWear® MF armband (Body Media Inc., AliphCom dba Jawbone®, Pittsburgh, PA, U.S.A.). This device detects activity contest using accelerometers and assesses daily energy expenditure. For allocation of the subjects, a computer-generated list of random numbers was used. The randomization sequence was created using SPSS 18 (SPSS, Inc., Chicago, IL, USA) statistical software and subjects were assigned to be tested or not for locomotor activity with a 1:1 allocation using random block sizes of 2, 4, and 6.

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
30 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 30 - 65 years
  • BMI 30 - 40 kg/m2
  • non-Insulin dependent diabetes

排除标准

  • Pregnancy
  • more than 3 anti-diabetic drugs

研究组 & 干预措施

Diet and Physical Activity Recording

Active Comparator

干预措施: Diet (Behavioral)

Diet and No Physical Activity Recording

Active Comparator

干预措施: Diet (Behavioral)

结局指标

主要结局

Body weight reduction

时间窗: 12 weeks

Changes in body weight (kg) within 12 weeks of diet

次要结局

  • Blood glucose(12 weeks)
  • Blood HbA1c(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Boschmann

Physician

Charite University, Berlin, Germany

相似试验