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

Not Applicable

• Conditions: Obesity; Type2 Diabetes; Overweight
• Interventions: Dietary Supplement: nutritional meal replacement

• Registration Number: NCT02984605
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Study Timeline

• Status Verified: 2016-11
• Study Start: 2016-12
• Study First Submitted: 2016-12-04
• Study First Submitted QC: 2016-12-04
• Last Update Submitted: 2016-12-04
• Study First Posted: 2016-12-07
• Last Update Posted: 2016-12-07
• Primary Completion: 2018-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

• Insulin dependent diabetes
• Thyroid disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional group	nutritional meal replacement	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

Primary Outcome Measures

Name	Time	Method
glycated hemoglobin	24 weeks