Effects of Nutrition Meal Replacement and Individualized Exercise Prescription on Type 2 Diabetes

Shanghai Jiao Tong University

Status: Unknown

Conditions: Overweight; Type2 Diabetes; Obesity

Treatments: Dietary Supplement: nutritional meal replacement

Study type: Interventional

Funder types: Other

Identifiers

NCT02984605

XH-16-046

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Insulin dependent diabetes
• Thyroid disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Interventional group

Experimental group

Description:

Arm：Hypoglycemic agents + Nutrition meal replacement \& exercise prescription Hypoglycemic agents in combined with 1 times a day with bags of nutritional meal replacement and exercise

Treatment:

Dietary Supplement: nutritional meal replacement

Control group

No Intervention group

Description:

Arm：Hypoglycemic agents without take nutrition meal replacement \& exercise prescription