Effects of Nutrition Meal Replacement and Individualized Exercise Prescription on Type 2 Diabetes
Primary Purpose
Overweight, Obesity, Type2 Diabetes
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
nutritional meal replacement
Sponsored by
About this trial
This is an interventional treatment trial for Overweight
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Interventional group
Control group
Arm 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
Arm:Hypoglycemic agents without take nutrition meal replacement & exercise prescription
Outcomes
Primary Outcome Measures
glycated hemoglobin
Secondary Outcome Measures
Full Information
NCT ID
NCT02984605
First Posted
December 4, 2016
Last Updated
December 4, 2016
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators
Shanghai University of Sports National Science Park, Yinhang Community Health Service Center of Yangpu District, Dinghai Community Health Service Center of Yangpu District, Kongjiang Community Health Service Center of Yangpu District, Daqiao Community Health Service Center of Yangpu District
1. Study Identification
Unique Protocol Identification Number
NCT02984605
Brief Title
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
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators
Shanghai University of Sports National Science Park, Yinhang Community Health Service Center of Yangpu District, Dinghai Community Health Service Center of Yangpu District, Kongjiang Community Health Service Center of Yangpu District, Daqiao Community Health Service Center of Yangpu District
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity, Type2 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interventional group
Arm Type
Experimental
Arm 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
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Arm:Hypoglycemic agents
without take nutrition meal replacement & exercise prescription
Intervention Type
Dietary Supplement
Intervention Name(s)
nutritional meal replacement
Intervention Description
1 times a day with bags of nutritional meal replacement + individualized exercise prescription
Primary Outcome Measure Information:
Title
glycated hemoglobin
Time Frame
24 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qing Su, MD
Phone
86(21)25077536
Email
suqingxinhua@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoyong Li, MD
Phone
86(21)25077538
Email
lixiaoyong0055@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming Cui, MD
Organizational Affiliation
YinXing Community Health Service Center of Yangpu District
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wenbin Liu, MD
Organizational Affiliation
Dinghai Community Health Service Center of Yangpu District
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiaoyi Che, MD
Organizational Affiliation
Kongjiang Community Health Service Center of Yangpu District
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hui Liu, MD
Organizational Affiliation
Daqiao Community Health Service Center of Yangpu District
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Nutrition Meal Replacement and Individualized Exercise Prescription on Type 2 Diabetes
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