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Strategy for weight Loss In postpartuM among woMEn with cardiovascular Risk exposure during pregnancy(SLIMMER): a multicenter randomized controlled trial

Strategy for weight Loss In postpartuM among woMEn with cardiovascular Risk exposure during pregnancy(SLIMMER): a multicenter randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061895
Enrollment
Unknown
Registered
2022-07-09
Start date
2022-08-01
Completion date
Unknown
Last updated
2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum obesity

Interventions

App push management + Smiglutide intervention group:App based on lifestyle push intervention, combined with smiglutide treatment
App management feedback group:App provides lifestyle intervention and timely feedback
App push management group:App carries out lifestyle push intervention

Sponsors

Tianjin Medical University General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-45 years, not breastfeeding within 1 year after delivery; 2. Body mass index (BMI) >= 28 kg/m^2; 3. Those who are diagnosed with gestational diabetes mellitus; 4. Those who are diagnosed with gestational hypertension, preeclampsia or eclampsia; 5. A person who has a negative pregnancy test and is able to adhere to contraception during the test; 6. Follow-up conditions, compliance, and voluntary subjects who signed informed consent. Except for one of the conditions that 3 and 4meet, all other conditions must be met at the same time.

Exclusion criteria

Exclusion criteria: Exclusion Criteria: 1. Previous abnormal history of blood glucose, blood pressure, and serum lipids; 2. Uncontrolled thyroid disease (thyroid-stimulating hormone (TSH) > 6.0 mIU/L or 2 times the upper limit of normal level or calcitonin >= 100 ng/L); 4. Impaired liver function (hepatic transaminases > 3 times the upper limit of normal level); 5. Impaired renal function (estimated glomerular filtration rate (eGFR) = 1.4 mg/dL); 6. History of heart disease: decompensated heart failure (NYHA: grade III or IV), unstable angina, and/or myocardial infarction within the past 12 months; 7. Previous surgical treatment of weight loss and postpartum treatment with anti-obesity drugs; 8. Allergy to GLP-1 RA; 9. Severe mental illnesses, including depression, schizophrenia, paranoid psychosis, bipolar disorder or mental retardation; 10. History of neurological disorders, including traumatic brain surgery; 11. Bleeding disorders; 12. Postpartum treatment with GLP-1 RA. Suspension or withdrawal of criteria: 1. The occurrence of intolerable drug-related adverse events; 2. Subjects do not follow the study procedure; 3. The subject is pregnant.

Design outcomes

Primary

MeasureTime frame
body weight change;

Secondary

MeasureTime frame
Insulin resistance;Ambulatory blood pressure;serum lipids;body fat percentage;Neonatal growth and development;Women's health-related quality of life, psychological indicators;

Countries

China

Contacts

Public ContactHan Cha

Tianjin Medical University General Hospital

tjhancha@tmu.edu+86 13920758936

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026