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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

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ClinicalTrials.gov Identifier: NCT02938026
Recruitment Status : Completed
First Posted : October 19, 2016
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Lorena Tsui Fun Cheung, Chinese University of Hong Kong

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 in Obese Procedure: Bariatric surgery Behavioral: Telephone Intensive Lifestyle Counselling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 141 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : May 1, 2016
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
Usual care
Experimental: Telephone intensive lifestyle counseling
Telephone intensive lifestyle counseling
Behavioral: Telephone Intensive Lifestyle Counselling
Experimental: Bariatric surgery
Bariatric surgery
Procedure: Bariatric surgery



Primary Outcome Measures :
  1. Change of HbA1c [ Time Frame: 1 year ]
  2. Change of weight [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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Responsible Party: Lorena Tsui Fun Cheung, PhD student in medical science, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT02938026     History of Changes
Other Study ID Numbers: Lifestyle-002
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases