Diabetes Mellitus Type 2 in ObeseNCT02938026
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
A study testing Bariatric surgery and Telephone Intensive Lifestyle Counselling in people with Diabetes Mellitus Type 2 in Obese, run by Chinese University of Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus Type 2 in Obese
- What is being tested?
- Bariatric surgery and Telephone Intensive Lifestyle Counselling
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2016to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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
- Diabetes Mellitus Type 2 in Obese
- Being tested
- Bariatric surgery, Telephone Intensive Lifestyle Counselling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or surgery
Telephone Intensive Lifestyle CounsellingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Usual care |
| Telephone intensive lifestyle counseling | Experimental | Telephone intensive lifestyle counseling Receives: Behavioral: Telephone Intensive Lifestyle Counselling |
| Bariatric surgery | Experimental | Bariatric surgery Receives: Procedure: Bariatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of HbA1c
Measured: 1 year
Change of weight
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study start1 May 2016
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2 in ObeseStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorena Tsui Fun Cheung, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02938026
- Sponsor's protocol ID
- Lifestyle-002
- Status last verified
- Jul 2018
- First submitted
- 17 Oct 2016
- Last updated
- 24 Jul 2018
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02938026
- Acronym / sponsor ID
- Lifestyle-002
- Conditions
- Diabetes Mellitus Type 2 in Obese
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 19 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Usual care |
| Telephone intensive lifestyle counseling | Experimental | Behavioral: Telephone Intensive Lifestyle CounsellingTelephone intensive lifestyle counseling |
| Bariatric surgery | Experimental | Procedure: Bariatric surgeryBariatric surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 - 65 years
- Chinese ethnicity
- BMI ≥27.5 kg/m2
- Diagnosis of T2DM
- No active cardiovascular diseases
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bariatric surgery | Procedure or surgery | Bariatric surgery |
| Telephone Intensive Lifestyle Counselling | Behavioural | Telephone intensive lifestyle counseling |
Primary outcome
Change of HbA1c
Time frame: 1 year
Change of weight
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Bariatric surgery and Telephone Intensive Lifestyle Counselling in people with Diabetes Mellitus Type 2 in Obese, run by Chinese University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of HbA1c (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2018.