NCT Number: NCT02938026
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
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.
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Telephone Intensive Lifestyle Counselling
BehavioralPrimary outcomes
-
Change of HbA1c
Time frame: 1 year
-
Change of weight
Time frame: 1 year
Sponsors and collaborators
Lead sponsor
Chinese University of Hong Kong
Other
Registry information
Important dates
- Study start
- 2016
- Primary completion
- 2018
- Study completion
- 2018
- First posted
- Oct 19, 2016
- Registry last updated
- Jul 24, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
A Randomised, Controlled Trial of a Low-energy Diet for Improving Functional Status in Heart Failure With PRESERVED Ejection Fraction Preserved Ejection Fraction
NCT05887271
Body Weight, Cardiovascular Diseases
Leicester, Leicestershire, United Kingdom
View Trial DetailsThe Effect of a Low-fat Vegan Dietary Intervention on Intracellular Lipid, Insulin Sensitivity, and Glycemic Control in Type 2 Diabetes
NCT06106035
Diabetes Mellitus, Diabetes Mellitus Type 2 in Obese
Washington D.C., District of Columbia, United States
View Trial DetailsThe Effects of Nutritional Intervention on Health Parameters in Participants With Type 2 Diabetes Mellitus
NCT06235762
COVID-19, Cardiovascular Diseases
São José do Rio Preto, São Paulo, Brazil
View Trial DetailsVLCD & Adjuvant Exercise Effect in Overweight Diabetic Men
NCT04957589
Diabetes Mellitus Type 2 in Obese
Derby, Derbyshire, United Kingdom
View Trial Details