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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

NCT02938026 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 141

Last updated 2018-07-24

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus Type 2 in Obese

Interventions

PROCEDURE

Bariatric surgery

BEHAVIORAL

Telephone Intensive Lifestyle Counselling

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-01
Primary Completion
2018-03-31
Completion
2018-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02938026 on ClinicalTrials.gov