Polycystic Ovary SyndromePhase 4NCT04876027
GLP-1 RAs in Patients With Polycystic Ovary Syndrome (PCOS)
A Phase 4 study testing GLP-1 RAs and calorie restricted diet in people with Polycystic Ovary Syndrome, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
Polycystic ovary syndrome (PCOS) is a common endocrine disorder, with a prevalence of 5% to 15% in premenopausal women. Patients with PCOS presents as abnormal menstruation, ovulation disorders and/or hyperandrogenemia, and often accompanied by insulin resistance and other metabolic abnormalities. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- GLP-1 RAs and calorie restricted diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2021to 10 May 2022
- Phase
- Phase 4
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female aged 18- 45;
- Meet 2003 Rotterdam criteria;
- overweight/obesity,BMI≥24kg/m2.
Who cannot join
- any contraindication to dulaglutide (known or suspected hypersensitivity to dulaglutide or related products, previous acute pancreatitis or chronic pancreatitis, inflammatory bowel disease; personal history or family history of medullary thyroid carcinoma, or personal history of multiple endocrine neoplasia type 2)；
- treatment with any other drugs that may interfere with the trial, including traditional Chinese medicine, contraceptives, metformin, GLP-1RA or pioglitazone within the last 3 months；
- chronic kidney disease or severe liver dysfunction；
- malignant tumors；
- mental illness;
- pregnancy or lactation；
- inflammatory bowel disease;
- recent participation in other weight-loss research projects within the last 3 months.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Tenth People' Hospital
Shanghai, Shanghai Municipality, 200072
About this study
Official title: Dulaglutide and Calorie Restrict Diet (CRD) in Overweight/Obese Patients With Polycystic Ovary Syndrome
Polycystic ovary syndrome (PCOS) is a common endocrine disorder, with a prevalence of 5% to 15% in premenopausal women. Patients with PCOS presents as abnormal menstruation, ovulation disorders and/or hyperandrogenemia, and often accompanied by insulin resistance and other metabolic abnormalities. Visceral fat dysfunction is an important factor in the onset of PCOS. GLP-1 receptor agonist is a glucagon-like peptide 1 analog, which is related to improving blood sugar control, weight loss and appetite suppression, and reducing cardiovascular risk. The purpose of this study was to compare whether the combined treatment of GLP-1 receptor agonists and calorie restrict diet reduced more visceral fat of overweight/obese patients with PCOS at the same weight loss (7%) compared with calorie restrict diet alone.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- GLP-1 RAs, calorie restricted diet
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP-1 RAsDrug
Also called Dulaglutide
GLP-1 receptor agonist is a glucagon-like peptide 1 analog, which is related to improving blood sugar control, weight loss and appetite suppression, and reducing cardiovascular risk.
calorie restricted dietOther
Calorie restricted diet can improve insulin sensitivity, liver fat in patients with visceral obesity, and metabolism and hormone levels in obese women with PCOS.
| Study group | Role | What they receive |
|---|---|---|
| GLP-1 RAs and calorie restrict diet group | Experimental | Intervention with GLP-1 RAs and calorie restrict diet until reaching the target weight loss(7%) Receives: Drug: GLP-1 RAs; Other: calorie restricted diet |
| calorie restrict diet group | Active comparator | Intervention with calorie restrict diet until reaching the target weight loss(7%) Receives: Other: calorie restricted diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change in visceral adipose tissue
the change in visceral adipose tissue (pretreatment-post-treatment) after achievement of the weight loss target
Measured: until achievement of the weight loss target,an average of 12 weeks
Secondary outcomes (32)
menstrual frequency
number of menstruation in a year
Measured: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
systolic blood pressure
systolic blood pressure (SBP), mmHg
Measured: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
diastolic blood pressure
diastolic blood pressure (DBP), mmHg
Measured: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
fasting plasma glucose
fasting plasma glucose (FPG), mmol/L
Measured: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
postprandial plasma glucose
postprandial plasma glucose (PPG), mmol/L
Measured: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
fasting insulin
fasting insulin (FINS), mU/L
Measured: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
postprandial insulin
postprandial insulin (PINS), mU/L
Measured: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
glycosylated hemoglobin A1c
glycosylated hemoglobin A1c (HbA1c), %
Measured: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
homeostasis model assessment of insulin resistance
homeostasis model assessment of insulin resistance (HOMA-IR)
Measured: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
alanine aminotransferase
alanine aminotransferase (ALT), U/L
Measured: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
aspartate aminotransferase
aspartate aminotransferase (AST), U/L
Measured: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Total cholesterol
Total cholesterol (TC), mmol/L
Measured: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Triglycerides
Triglycerides (TG), mmol/L
Measured: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
high-density lipoprotein cholesterol
high-density lipoprotein cholesterol (HDL-c), mmol/L
Measured: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
low-density lipoprotein cholesterol
low-density lipoprotein cholesterol (LDL-c), mmol/L
Measured: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Creatinine
Creatinine (Cr), umol/L
Measured: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
serum uric acid
serum uric acid (SUA), umol/L
Measured: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
luteinizing hormone
luteinizing hormone (LH), IU/L
Measured: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
follicle-stimulating hormone
follicle-stimulating hormone (FSH), IU/L
Measured: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
pituitary prolactin
pituitary prolactin (PRL), mIU/L
Measured: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
total testosterone
total testosterone (TT), ng/ml
Measured: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
free testosterone
free testosterone (FT), pg/ml
Measured: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Sex hormone binding globulin
Sex hormone binding globulin (SHBG), nmol/L
Measured: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Androstenedione
Androstenedione (AD), ng/ml
Measured: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
dehydroepiandrosterone sulfate
dehydroepiandrosterone sulfate (DHEAS), ug/dl
Measured: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
controlled attenuation parameter
controlled attenuation parameter (CAP), dB/m
Measured: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
liver stiffness measurement
liver stiffness measurement (LSM), kPa
Measured: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
total body fat
percentage of total body fat, %
Measured: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
total body lean
percentage of total body lean, %
Measured: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
total fat mass
total fat mass, kg
Measured: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
total lean mass
total lean mass, kg
Measured: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
the change in subcutaneous adipose tissue
the change in subcutaneous adipose tissue (pretreatment-post-treatment) after achievement of the weight loss target
Measured: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start15 May 2021
- Primary completion30 Apr 2022
- Study completion10 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Manna, Shanghai 10th People's Hospital
- Investigators
- Shen Qu, Dr, Study chair, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04876027
- Sponsor's protocol ID
- GLP-1RAs PCOS
- Status last verified
- Aug 2022
- First submitted
- 29 Apr 2021
- Last updated
- 4 Aug 2022
- 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 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dulaglutide and Calorie Restrict Diet (CRD) in Overweight/Obese Patients With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT04876027
- Acronym / sponsor ID
- GLP-1RAs PCOS
- Conditions
- Polycystic Ovary Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 10 May 2022 (actual)
- First posted
- 6 May 2021 (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.
Polycystic ovary syndrome (PCOS) is a common endocrine disorder, with a prevalence of 5% to 15% in premenopausal women. Patients with PCOS presents as abnormal menstruation, ovulation disorders and/or hyperandrogenemia, and often accompanied by insulin resistance and other metabolic abnormalities. Visceral fat dysfunction is an important factor in the onset of PCOS. GLP-1 receptor agonist is a glucagon-like peptide 1 analog, which is related to improving blood sugar control, weight loss and appetite suppression, and reducing cardiovascular risk. The purpose of this study was to compare whether the combined treatment of GLP-1 receptor agonists and calorie restrict diet reduced more visceral fat of overweight/obese patients with PCOS at the same weight loss (7%) compared with calorie restrict diet alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLP-1 RAs and calorie restrict diet group | Experimental | Drug: GLP-1 RAs, Other: calorie restricted dietIntervention with GLP-1 RAs and calorie restrict diet until reaching the target weight loss(7%) |
| calorie restrict diet group | Active comparator | Other: calorie restricted dietIntervention with calorie restrict diet until reaching the target weight loss(7%) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female aged 18- 45;
- Meet 2003 Rotterdam criteria;
- overweight/obesity,BMI≥24kg/m2.
Key exclusion criteria (8 listed)
- any contraindication to dulaglutide (known or suspected hypersensitivity to dulaglutide or related products, previous acute pancreatitis or chronic pancreatitis, inflammatory bowel disease; personal history or family history of medullary thyroid carcinoma, or personal history of multiple endocrine neoplasia type 2)；
- treatment with any other drugs that may interfere with the trial, including traditional Chinese medicine, contraceptives, metformin, GLP-1RA or pioglitazone within the last 3 months；
- chronic kidney disease or severe liver dysfunction；
- malignant tumors；
- mental illness;
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 |
|---|---|---|
| GLP-1 RAsAlso: DulaglutideGLP-1 receptor agonist is a glucagon-like peptide 1 analog, which is related to improving blood sugar control, weight loss and appetite suppression, and reducing cardiovascular risk. | Drug | GLP-1 RAs and calorie restrict diet group |
| calorie restricted dietCalorie restricted diet can improve insulin sensitivity, liver fat in patients with visceral obesity, and metabolism and hormone levels in obese women with PCOS. | Other | GLP-1 RAs and calorie restrict diet group, calorie restrict diet group |
Primary outcome
the change in visceral adipose tissue
Time frame: until achievement of the weight loss target,an average of 12 weeks
the change in visceral adipose tissue (pretreatment-post-treatment) after achievement of the weight loss target
32 secondary outcomes
menstrual frequency
Time frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
systolic blood pressure
Time frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
diastolic blood pressure
Time frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
fasting plasma glucose
Time frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
postprandial plasma glucose
Time frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
fasting insulin
Time frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
postprandial insulin
Time frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
glycosylated hemoglobin A1c
Time frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
homeostasis model assessment of insulin resistance
Time frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
alanine aminotransferase
Time frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
aspartate aminotransferase
Time frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Total cholesterol
Time frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Triglycerides
Time frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
high-density lipoprotein cholesterol
Time frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
low-density lipoprotein cholesterol
Time frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Creatinine
Time frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
serum uric acid
Time frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
luteinizing hormone
Time frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
follicle-stimulating hormone
Time frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
pituitary prolactin
Time frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
total testosterone
Time frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
free testosterone
Time frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Sex hormone binding globulin
Time frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
Androstenedione
Time frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
dehydroepiandrosterone sulfate
Time frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
controlled attenuation parameter
Time frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
liver stiffness measurement
Time frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
total body fat
Time frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
total body lean
Time frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
total fat mass
Time frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
total lean mass
Time frame: from randomization to the time of achievement of the weight loss target, an average of 12 weeks
the change in subcutaneous adipose tissue
Time frame: from randomization to the time of achievement of the weight loss target, an average of 12 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 4 Aug 2022.
- 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.
Shen Qu, Dr study chair
Shanghai 10th People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing GLP-1 RAs and calorie restricted diet in people with Polycystic Ovary Syndrome, run by Shanghai 10th People's 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 3 inclusion and 8 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 4 Aug 2022. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
the change in visceral adipose tissue (time frame: until achievement of the weight loss target,an average of 12 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 4 Aug 2022.