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

Study Overview
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Brief Summary
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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: 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. 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.

Conditions
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Diabetes Mellitus Type 2 in Obese

Intervention / Treatment
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* Procedure: Bariatric surgery
* Behavioral: Telephone Intensive Lifestyle Counselling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Usual care | |
| Experimental: Telephone intensive lifestyle counseling<br>Telephone intensive lifestyle counseling | Behavioral: Telephone Intensive Lifestyle Counselling<br> <br> |
| Experimental: Bariatric surgery<br>Bariatric surgery | Procedure: Bariatric surgery<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of HbA1c |  | 1 year | 
| Change of weight |  | 1 year |