跳至主要内容
临床试验/NCT02938026
NCT02938026已完成不适用

Changes of Diet, Physical Activity and Sleep Pattern and Their Effects on Glycemic and Weight Control in Hong Kong Chinese Obese Patients With Type 2 Diabetes After Bariatric Surgery Compared to Telephone Intensive Lifestyle Counselling

Chinese University of Hong Kong0 个研究点目标入组 141 人开始时间: 2016年5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
141
主要终点
Change of HbA1c

研究概览

简要总结

Nutrition therapy is recognized as one of the crucial components for the standard treatment of diabetes along with physical activity and drug therapy. Of note, dietary habits are culture specific and hence understanding the dietary intake, eating behavior and physical activity level of the local population is important to formulate effective nutrition and lifestyle strategies. Weight control is a major therapeutic challenge because many conventionally used anti-diabetic agents, such as sulphonylurea and insulin, can cause weight gain, thus setting up a vicious cycle with increasing insulin resistance due to increasing levels of free fatty acids from adipose tissues . Although intensive face-to-face lifestyle intervention program has showed that even modest weight loss in people with Type 2 diabetes (T2DM) who were overweight or obese was associated with improvements in glycemic control and associated conditions, it may not be feasible in public hospital setting in Hong Kong due to factors such as limited resources, scheduling, patient's employment and willingness for frequent travel to the clinic. Hence, alternative strategies such as a combination of face- to-face individual dietary and lifestyle consultation together with telephone intensive lifestyle reinforcement program will likely to be an useful strategy to engage those obese T2DM patients through frequent individual contacts. On the other hand, bariatric surgery has emerged as an impressive therapeutic option for poorly control obese T2DM patients.

Realizing there is a knowledge gap in understanding the lifestyle factors in the Hong Kong Chinese obese T2DM patients, we therefore propose to conduct a 1-year prospective clinical trial with two main objectives:

  1. To study and compare the glycemic and weight improvement after bariatric surgery versus a telephone intensive lifestyle intervention program for 1 year in Hong Kong Chinese obese patients with type 2 diabetes.
  2. To investigate the effect of lifestyle factors including dietary intake, eating behaviors and physical activity level on the glycemic and weight control of Hong Kong Chinese obese patients with type 2 diabetes.

研究设计

研究类型
Interventional
分配方式
Non 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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 - 65 years
  • Chinese ethnicity
  • BMI ≥27.5 kg/m2
  • Diagnosis of T2DM
  • No active cardiovascular diseases
  • ASA grade II or below (for the bariatric surgery group)
  • Able to read Chinese and give informed written consent

排除标准

  • Type 1 diabetes mellitus
  • End-stage renal failure requiring dialysis or chronic kidney disease (CKD) stage 4 or above
  • Malignancy diagnosed within 3 years
  • Major psychiatric illness
  • Pregnancy or lactation
  • Significant anaesthetic risk ASA grade III or above (for the bariatric surgery group)
  • Any medical illness or condition as judged by the investigators as ineligible to participate the study

研究组 & 干预措施

Control

No Intervention

Usual care

Telephone intensive lifestyle counseling

Experimental

Telephone intensive lifestyle counseling

干预措施: Telephone Intensive Lifestyle Counselling (Behavioral)

Bariatric surgery

Experimental

Bariatric surgery

干预措施: Bariatric surgery (Procedure)

结局指标

主要结局

Change of HbA1c

时间窗: 1 year

Change of weight

时间窗: 1 year

次要结局

未报告次要终点

研究者

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

Lorena Tsui Fun Cheung

PhD student in medical science

Chinese University of Hong Kong

相似试验