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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
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

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

    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
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    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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