Type 2 Diabetes Mellitus in Obese Clinical Trial
NCT number | NCT02937987 |
Other study ID # | Lifestyle-001 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 2016 |
Est. completion date | March 2018 |
Verified date | January 2019 |
Source | Chinese University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The objective of this study is to describe and examine the dietary intake, eating behavior and physical activity level of a cohort of Hong Kong Chinese with T2DM and their association with weight and glycemic control at baseline and 1 year follow-up. The investigators hypothesize that Hong Kong Chinese T2DM patients with unhealthy dietary intake and pattern and low physical activity level are associated with poorer glycemic and weight control, and there will be no improvement with weight and glycemic control under usual care after 1 year.
Status | Completed |
Enrollment | 211 |
Est. completion date | March 2018 |
Est. primary completion date | March 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Male or female of Chinese ethnicity 2. Diagnosis of T2DM 3. Able to read Chinese and give informed written consents 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. Pregnancy or lactation 5. Any medical illness or condition as judged by the investigators as ineligible to participate the study |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of HbA1c | 1 year | ||
Primary | Change of Weight | 1 year |
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