MetforminNCT05779644
Effects of GLP-1RA on Body Weight, Metabolism and Fat Distribution in Overweight/Obese Patients With Type 2 Diabetes Mellitus
A study testing Liraglutide, Semaglutide and Metformin in people with Metformin and Obesity, Abdominal, run by RenJi Hospital at 1 site in China.
Trial summary
The purpose of this study is to analyze the effects of GLP-1RA on blood glucose, body weight, glucose and lipid metabolism and fat distribution in overweight/obese patients with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Metformin, Obesity, Abdominal, Diabetes Mellitus, Type 2
- What is being tested?
- Liraglutide, Semaglutide and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 23 Feb 2023to 23 Feb 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-65 years old
- BMI≥24kg/㎡, or waist circumference: > 85cm (for male) or > 80cm (for female)
- Has been diagnosed with type 2 diabetes mellitus
- Good blood glucose control in recent three months: random blood sugar < 14mmol/L and HbA1c 6-9%
- Not received any drugs affecting glucose and lipid metabolism or weight loss surgery in the past one month
Who cannot join
- Abnormal weight gain caused by other endocrine diseases
- Severe metabolic diseases, such as diabetic ketoacidosis, hypertonic hyperglycemia
- Type 1 diabetes or other special types of diabetes
- Used drugs affecting glycolipid metabolism in the past three months
- Severe bleeding tendency that unable to complete venous blood collection
- Patients with MRI contraindications
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- Severe renal insufficiency or severe liver insufficiency
- Patients with advanced malignant tumors
- Serious cardiovascular and cerebrovascular diseases
- Rheumatic and immune diseases
- Pregnant and lactating women
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200127
Du Mengyang, MM, 18051756952, dumengyang2022@163.com
About this study
The purpose of this study is to analyze the effects of GLP-1RA on blood glucose, body weight, glucose and lipid metabolism and fat distribution in overweight/obese patients with type 2 diabetes mellitus.
Read the detailed description
Specific research contents: To study the characteristics of glucose and lipid metabolism and fat distribution in overweight/obesity patients with type 2 diabetes mellitus; liraglutide/ semaglutide/ metformin will be applied to patients for one year, and the changes of lipid metabolism and fat distribution in overweight/obese patients with type 2 diabetes and the differences among the three groups will be analyzed before and after treatment. The metabolomic changes of overweight/obese patients with type 2 diabetes before and after medication and the differences among the three groups will be analyzed. Explore the correlation between visceral fat content, glucose and lipid metabolism, inflammatory factors and other biochemical indicators and metabolomics.
- Conditions
- Metformin, Obesity, Abdominal, Diabetes Mellitus, Type 2, Abdominal Fat, Non-Alcoholic Fatty Liver Disease, Metabolism Disorder, Glucose
- Being tested
- Liraglutide, Semaglutide, Metformin
- Keywords
- Metformin, Glucagon-Like Peptide-1 Receptor, Obesity, Abdominal, Diabetes Mellitus, Type 2, Non-Alcoholic Fatty Liver Disease, Metabolism Disorder, Glucose
- Medical subject headings
- Obesity, Abdominal, Diabetes Mellitus, Type 2, Non-alcoholic Fatty Liver Disease, Glucose Metabolism Disorders, Lipid Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiraglutideDrug
Liraglutide is injected once a day.
SemaglutideDrug
Semaglutide is injected once a week.
MetforminDrug
Metformin is taken orally daily.
| Study group | Role | What they receive |
|---|---|---|
| Liraglutide group | Experimental | Liraglutide is injected once a day. Receives: Drug: Liraglutide |
| Semaglutide group | Experimental | Semaglutide is injected once a week. Receives: Drug: Semaglutide |
| Metformin group | Experimental | Metformin is taken orally daily. Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose
Glucose metabolism index
Measured: The twelfth week of treatment
Blood insulin
Glucose metabolism index
Measured: The twelfth week of treatment
Total cholesterol
Lipid metabolism index
Measured: The twelfth week of treatment
Triglyceride
Lipid metabolism index
Measured: The twelfth week of treatment
Lipoprotein
Lipid metabolism index
Measured: The twelfth week of treatment
Weight
Measure fasting weight
Measured: The twelfth week of treatment
Abdominal fat distribution
Use Magnetic resonance imaging-proton density fat fraction to measure fat accumulation in the liver, pancreas and abdomen.
Measured: The twelfth week of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start23 Feb 2023
- Primary completion23 Feb 2025 (estimated)
- Study completion23 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetforminStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Ma, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779644
- Sponsor's protocol ID
- IIT-2022-0245
- Status last verified
- May 2023
- First submitted
- 9 Mar 2023
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of GLP-1RA on Body Weight, Metabolism and Fat Distribution in Overweight/Obese Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05779644
- Acronym / sponsor ID
- IIT-2022-0245
- Conditions
- Metformin, Obesity, Abdominal, Diabetes Mellitus, Type 2, Abdominal Fat, Non-Alcoholic Fatty Liver Disease, Metabolism Disorder, Glucose
- Keywords
- Metformin, Glucagon-Like Peptide-1 Receptor, Obesity, Abdominal, Diabetes Mellitus, Type 2, Non-Alcoholic Fatty Liver Disease, Metabolism Disorder, Glucose
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- 23 Feb 2025 (estimated)
- Study completion
- 23 Feb 2025 (estimated)
- First posted
- 22 Mar 2023 (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.
The purpose of this study is to analyze the effects of GLP-1RA on blood glucose, body weight, glucose and lipid metabolism and fat distribution in overweight/obese patients with type 2 diabetes mellitus.
Detailed description
Specific research contents: To study the characteristics of glucose and lipid metabolism and fat distribution in overweight/obesity patients with type 2 diabetes mellitus; liraglutide/ semaglutide/ metformin will be applied to patients for one year, and the changes of lipid metabolism and fat distribution in overweight/obese patients with type 2 diabetes and the differences among the three groups will be analyzed before and after treatment. The metabolomic changes of overweight/obese patients with type 2 diabetes before and after medication and the differences among the three groups will be analyzed. Explore the correlation between visceral fat content, glucose and lipid metabolism, inflammatory factors and other biochemical indicators and metabolomics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Liraglutide group | Experimental | Drug: LiraglutideLiraglutide is injected once a day. |
| Semaglutide group | Experimental | Drug: SemaglutideSemaglutide is injected once a week. |
| Metformin group | Experimental | Drug: MetforminMetformin is taken orally daily. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18-65 years old
- BMI≥24kg/㎡, or waist circumference: > 85cm (for male) or > 80cm (for female)
- Has been diagnosed with type 2 diabetes mellitus
- Good blood glucose control in recent three months: random blood sugar < 14mmol/L and HbA1c 6-9%
- Not received any drugs affecting glucose and lipid metabolism or weight loss surgery in the past one month
Key exclusion criteria (11 listed)
- Abnormal weight gain caused by other endocrine diseases
- Severe metabolic diseases, such as diabetic ketoacidosis, hypertonic hyperglycemia
- Type 1 diabetes or other special types of diabetes
- Used drugs affecting glycolipid metabolism in the past three months
- Severe bleeding tendency that unable to complete venous blood collection
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 |
|---|---|---|
| LiraglutideLiraglutide is injected once a day. | Drug | Liraglutide group |
| SemaglutideSemaglutide is injected once a week. | Drug | Semaglutide group |
| MetforminMetformin is taken orally daily. | Drug | Metformin group |
Primary outcome
Blood glucose
Time frame: The twelfth week of treatment
Glucose metabolism index
Blood insulin
Time frame: The twelfth week of treatment
Glucose metabolism index
Total cholesterol
Time frame: The twelfth week of treatment
Lipid metabolism index
Triglyceride
Time frame: The twelfth week of treatment
Lipid metabolism index
Lipoprotein
Time frame: The twelfth week of treatment
Lipid metabolism index
Weight
Time frame: The twelfth week of treatment
Measure fasting weight
Abdominal fat distribution
Time frame: The twelfth week of treatment
Use Magnetic resonance imaging-proton density fat fraction to measure fat accumulation in the liver, pancreas and abdomen.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- 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.
Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liraglutide, Semaglutide and Metformin in people with Metformin and Obesity, Abdominal, run by RenJi Hospital at 1 site 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 5 inclusion and 11 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 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose (time frame: The twelfth week of treatment). The study lists 7 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 16 May 2023.