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

NCT ID: NCT02984605

Last Updated: 2016-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Overweight Obesity Type2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Interventional group

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

Group Type EXPERIMENTAL

nutritional meal replacement

Intervention Type DIETARY_SUPPLEMENT

1 times a day with bags of nutritional meal replacement + individualized exercise prescription

Control group

Arm：Hypoglycemic agents

without take nutrition meal replacement \& exercise prescription

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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nutritional meal replacement

1 times a day with bags of nutritional meal replacement + individualized exercise prescription

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Insulin dependent diabetes
* Thyroid disease
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai University of Sports National Science Park

UNKNOWN

Sponsor Role collaborator

Yinhang Community Health Service Center of Yangpu District

UNKNOWN

Sponsor Role collaborator

Dinghai Community Health Service Center of Yangpu District

UNKNOWN

Sponsor Role collaborator

Kongjiang Community Health Service Center of Yangpu District

UNKNOWN

Sponsor Role collaborator

Daqiao Community Health Service Center of Yangpu District

UNKNOWN

Sponsor Role collaborator

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ming Cui, MD

Role: PRINCIPAL_INVESTIGATOR

YinXing Community Health Service Center of Yangpu District

Wenbin Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Dinghai Community Health Service Center of Yangpu District

Xiaoyi Che, MD

Role: PRINCIPAL_INVESTIGATOR

Kongjiang Community Health Service Center of Yangpu District

Hui Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Daqiao Community Health Service Center of Yangpu District

Central Contacts

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Qing Su, MD

Role: CONTACT

Phone: 86(21)25077536

Email: [email protected]

Xiaoyong Li, MD

Role: CONTACT

Phone: 86(21)25077538

Email: [email protected]

Other Identifiers

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XH-16-046

Identifier Type: -

Identifier Source: org_study_id