Overweight and ObesityNCT04469400
Lifestyle Intervention for Patients With Impaired Glucose Regulation
A study testing Low fat diet intensive intervention and Low-Carbon Water Diet Intensive Intervention in people with Overweight and Obesity, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 8 sites in China.
Trial summary
Impaired glucose regulation (IGR) is closely related to overweight/obesity. By studying different dietary patterns (energy-limited diet vs. low-carbohydrate diet) and intensive lifestyle interventions combined with blood glucose monitoring, glucose regulation of overweight/obesity is affected. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Low fat diet intensive intervention and Low-Carbon Water Diet Intensive Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 8 sitesChina
- Study dates
- 1 May 2020to 31 Dec 2022
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65 years old ② Fasting blood glucose is between 5.6-6.9 mmol/L (100-125mg/dL) or oral glucose tolerance test (OGTT) 2h plasma glucose (2h-PG) is 7.8-11.1 mmol/L (140-200 mg/dL)
- 24 kg/m2 ≤ BMI ≤ 35 kg/m2
- Those who are willing to accept assessment and sign informed consent.
Who cannot join
- Patients diagnosed with diabetes or undergoing diabetes treatment;
- Receiving drugs or surgery for weight loss at present or in the past 3 months;
- Receiving corticosteroid or thyroid hormone treatment;
- Secondary obesity caused by endocrine, genetic, metabolic and central nervous system diseases;
- Patients with abnormal liver function (alanine aminotransferase or/and aspartate aminotransferase exceeding the upper limit of normal value 3 times); patients with abnormal renal function (serum creatinine exceeding the upper limit of normal value); suffering from kidney disease and other diseases that need to control protein intake;
- Diseases affecting the digestion and absorption of food (such as chronic diarrhea, constipation, severe gastrointestinal inflammation, active gastrointestinal ulcer, gastrointestinal resection, cholecystitis/cholecystectomy, etc.); ⑦ Suffering from cardiovascular and cerebrovascular diseases, grade 3 hypertension, chronic hepatitis, malignant tumors, anemia, mental illness and memory disorders, epilepsy and other diseases; ⑧ Suffering from infectious diseases such as active tuberculosis and AIDS; ⑨ During pregnancy or lactation; ⑩Patients with physical disabilities and clinicians think it is not suitable to participate in the study (for example, have a serious disease not included in the discharge criteria) or are unwilling to participate in this study.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Cixi People's Hospital
Cixi, Zhejiang, 315300
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Jinhua municipal central hospital
Jinhua, Zhejiang, 321000
Lishui People's Hospital
Lishui, Zhejiang, 323020
Ningbo Huamei Hospital, University of Chinese Academy of Sciences
Ningbo, Zhejiang, 315010
Shaoxing People's Hospital
Shaoxing, Zhejiang, 312000
The first affiliated hospital of Wenzhou medical university
Wenzhou, Zhejiang, 325000
Yuyao People's Hospital
Yuyao, Zhejiang, 315400
About this study
Official title: Study on Lifestyle Intervention for Patients With Impaired Glucose Regulation
Impaired glucose regulation (IGR) is closely related to overweight/obesity. By studying different dietary patterns (energy-limited diet vs. low-carbohydrate diet) and intensive lifestyle interventions combined with blood glucose monitoring, glucose regulation of overweight/obesity is affected. To improve the blood glucose and related metabolic indexes of patients with impaired (IGR), establish 1-2 clinical intervention programs for impaired glucose regulation.
- Conditions
- Overweight and Obesity
- Being tested
- Low fat diet intensive intervention, Low-Carbon Water Diet Intensive Intervention
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low fat diet intensive interventionDietary supplement
education and Compound protein solid beverage
Low-Carbon Water Diet Intensive InterventionOther
education and Nutrition bar
| Study group | Role | What they receive |
|---|---|---|
| Group1 | No intervention | Researchers conduct health education on patients, including dietary guidance, physical activity guidance, psychological behavior counseling, etc. |
| Group2 | Experimental | In addition to education, the subjects will consume 2 composite protein solid drinks per day, in conjunction with the three-meal diet to increase satiety and intake of sufficient nutrients Receives: Dietary Supplement: Low fat diet intensive intervention |
| Group3 | Experimental | In addition to education, the subjects will consume 2 nutrition bars daily to replace the staple food of daily lunch and dinner to help reduce carbohydrate intake and intake of sufficient nutrients Receives: Other: Low-Carbon Water Diet Intensive Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting blood glucose
Measured: ten weeks
Blood glucose 2 hours after meal
Measured: ten weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start1 May 2020
- Primary completion1 Feb 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pianhong Zhang, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04469400
- Sponsor's protocol ID
- 2019-317
- Status last verified
- Jul 2021
- First submitted
- 17 Jun 2020
- Last updated
- 24 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Lifestyle Intervention for Patients With Impaired Glucose Regulation
- ClinicalTrials.gov ID
- NCT04469400
- Acronym / sponsor ID
- 2019-317
- Conditions
- Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 14 Jul 2020 (actual)
- 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.
Impaired glucose regulation (IGR) is closely related to overweight/obesity. By studying different dietary patterns (energy-limited diet vs. low-carbohydrate diet) and intensive lifestyle interventions combined with blood glucose monitoring, glucose regulation of overweight/obesity is affected. To improve the blood glucose and related metabolic indexes of patients with impaired (IGR), establish 1-2 clinical intervention programs for impaired glucose regulation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group1 | No intervention | –Researchers conduct health education on patients, including dietary guidance, physical activity guidance, psychological behavior counseling, etc. |
| Group2 | Experimental | Dietary Supplement: Low fat diet intensive interventionIn addition to education, the subjects will consume 2 composite protein solid drinks per day, in conjunction with the three-meal diet to increase satiety and intake of sufficient nutrients |
| Group3 | Experimental | Other: Low-Carbon Water Diet Intensive InterventionIn addition to education, the subjects will consume 2 nutrition bars daily to replace the staple food of daily lunch and dinner to help reduce carbohydrate intake and intake of sufficient nutrients |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-65 years old ② Fasting blood glucose is between 5.6-6.9 mmol/L (100-125mg/dL) or oral glucose tolerance test (OGTT) 2h plasma glucose (2h-PG) is 7.8-11.1 mmol/L (140-200 mg/dL)
Key exclusion criteria (6 listed)
- Patients diagnosed with diabetes or undergoing diabetes treatment;
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 |
|---|---|---|
| Low fat diet intensive interventioneducation and Compound protein solid beverage | Dietary supplement | Group2 |
| Low-Carbon Water Diet Intensive Interventioneducation and Nutrition bar | Other | Group3 |
Primary outcome
Fasting blood glucose
Time frame: ten weeks
Blood glucose 2 hours after meal
Time frame: ten weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- 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.
Pianhong Zhang principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low fat diet intensive intervention and Low-Carbon Water Diet Intensive Intervention in people with Overweight and Obesity, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 8 sites in China.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting blood glucose (time frame: ten weeks). The study lists 2 primary outcomes in all. 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 24 Jun 2024.