Clinical trial NCT02984605: Effects of Nutrition Meal Replacement and Individualized Exercise Prescription on Type 2 Diabetes
Official title: Effects of Nutrition Meal Replacement and Individualized Exercise Prescription on Metabolism in Overweight and Obese Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight
Obesity
Type2 Diabetes
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai University of Sports National Science Park
name: Yinhang Community Health Service Center of Yangpu District
name: Dinghai Community Health Service Center of Yangpu District
name: Kongjiang Community Health Service Center of Yangpu District
name: Daqiao Community Health Service Center of Yangpu District
First posted: 2016-12-07
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the nutritional meal replacement and individualized exercise prescription intervention on overweight and obese type 2 diabetes mellitus. Half of participants will receive nutritional meal replacement and individualized exercise prescription on the basis of conventional glucose-lowering treatment, while the other half will only receive conventional glucose-lowering treatment.

Detailed description: Diabetes mellitus is a chronic metabolic disease which seriously threatens people's health at present. Although new drugs for the treatment of diabetes continue to emerge, but the effect of diabetes treatment is still not satisfactory. Medical nutrition therapy (nutrition therapy medical, MNT) and exercise therapy are essential measures for prevention and control of diabetes at any stage of the natural course of the disease, especially for the overweight and obese patients with type 2 diabetes. However, at present, the majority of patients could not get the guide from nutrition specialist and sports specialist. In addition, the existing diet programs are often more complex, difficult to implement and adhere to in daily life, and exercise programs are often lack of targeted. In view of this, the Shanghai peak Sports Management Co., Ltd. developed a kind of nutritional meal replacement for weight loss. The nutritional powder has the characteristics of high nutrition, low calorie, low glycemic and strong satiety, and the heat is only 126kcal, and have a good sense of satiety. Studies have shown that 1 times a day with bags of nutritional meal replacement instead of 1 meals for obese people have a role in weight loss. In theory, the meal is also suitable for diabetes patients, especially overweight and obese type 2 diabetes, such as the combination of individual exercise prescription may be better, but there is still a lack of relevant research. In view of this, we proposed a joint sports workers, explore nutritional and individualized exercise prescription intervention on overweight and obese type 2 diabetes mellitus, to explore suitable for China's diabetes lifestyle intervention measures, improve the level of prevention and treatment of diabetes in China.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of overweight and obesity type 2 diabetes
* Must be able to swallow tablets

Exclusion Criteria:

* Insulin dependent diabetes
* Thyroid disease

Primary outcomes:
measure: glycated hemoglobin
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: YinXing Community Health Service Center of Yangpu District
name: Ming Cui, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dinghai Community Health Service Center of Yangpu District
name: Wenbin Liu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kongjiang Community Health Service Center of Yangpu District
name: Xiaoyi Che, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Daqiao Community Health Service Center of Yangpu District
name: Hui Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: