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

Obesity Clinical Trial

Official title:

Effects of Nutrition Meal Replacement and Individualized Exercise Prescription on Metabolism in Overweight and Obese Type 2 Diabetes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02984605
• Other study ID #: XH-16-046
• Status: Not yet recruiting
• Phase: N/A
• First received: December 4, 2016
• Last updated: December 4, 2016
• Start date: December 2016
• Est. completion date: December 2020

Study information

• Verified date: November 2016
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Qing Su, MD
• Phone: 86(21)25077536
• Email: suqingxinhua[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2020
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity
• Overweight
• Type2 Diabetes

Intervention

Dietary Supplement:
• nutritional meal replacement
1 times a day with bags of nutritional meal replacement + individualized exercise prescription

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	Daqiao Community Health Service Center of Yangpu District, Dinghai Community Health Service Center of Yangpu District, Kongjiang Community Health Service Center of Yangpu District, Shanghai University of Sports National Science Park, Yinhang Community Health Service Center of Yangpu District

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glycated hemoglobin		24 weeks	No