OverweightNCT02984605
Effects of Nutrition Meal Replacement and Individualized Exercise Prescription on Type 2 Diabetes
A study testing nutritional meal replacement in people with Overweight and Obesity, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Overweight, Obesity, Type2 Diabetes
- What is being tested?
- nutritional meal replacement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of overweight and obesity type 2 diabetes
- Must be able to swallow tablets
Who cannot join
- Insulin dependent diabetes
- Thyroid disease
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Nutrition Meal Replacement and Individualized Exercise Prescription on Metabolism in Overweight and Obese Type 2 Diabetes
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.
Read the 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.
- Conditions
- Overweight, Obesity, Type2 Diabetes
- Being tested
- nutritional meal replacement
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutritional meal replacementDietary supplement
1 times a day with bags of nutritional meal replacement + individualized exercise prescription
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | 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 Receives: Dietary Supplement: nutritional meal replacement |
| Control group | No intervention | Arm：Hypoglycemic agents without take nutrition meal replacement \& exercise prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
glycated hemoglobin
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Ming Cui, MD, Principal investigator, YinXing Community Health Service Center of Yangpu DistrictWenbin Liu, MD, Principal investigator, Dinghai Community Health Service Center of Yangpu DistrictXiaoyi Che, MD, Principal investigator, Kongjiang Community Health Service Center of Yangpu DistrictHui Liu, MD, Principal investigator, Daqiao Community Health Service Center of Yangpu District
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02984605
- Sponsor's protocol ID
- XH-16-046
- Status last verified
- Nov 2016
- First submitted
- 4 Dec 2016
- Last updated
- 7 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nutrition Meal Replacement and Individualized Exercise Prescription on Metabolism in Overweight and Obese Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02984605
- Acronym / sponsor ID
- XH-16-046
- Conditions
- Overweight, Obesity, Type2 Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- 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
- Study start
- Dec 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 7 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Dietary Supplement: nutritional meal replacementArm：Hypoglycemic agents + Nutrition meal replacement \& exercise prescription Hypoglycemic agents in combined with 1 times a day with bags of nutritional meal replacement and exercise |
| Control group | No intervention | –Arm：Hypoglycemic agents without take nutrition meal replacement \& exercise prescription |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of overweight and obesity type 2 diabetes
- Must be able to swallow tablets
Key exclusion criteria (2 listed)
- Insulin dependent diabetes
- Thyroid disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nutritional meal replacement1 times a day with bags of nutritional meal replacement + individualized exercise prescription | Dietary supplement | Interventional group |
Primary outcome
glycated hemoglobin
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming Cui, MD principal investigator
YinXing Community Health Service Center of Yangpu District
Wenbin Liu, MD principal investigator
Dinghai Community Health Service Center of Yangpu District
Xiaoyi Che, MD principal investigator
Kongjiang Community Health Service Center of Yangpu District
Questions about this trial
What is this clinical trial studying?
A study testing nutritional meal replacement in people with Overweight and Obesity, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qing Su, MD (86(21)25077536, suqingxinhua@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glycated hemoglobin (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2016.