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Evaluation of the effect of Intra-Gastrointestinal Fiber Microspheres Assisted Lifestyle Intervention in Patients with Post-Bariatric Weight Regain

Evaluation of the effect of Intra-Gastrointestinal Fiber Microspheres Assisted Lifestyle Intervention in Patients with Post-Bariatric Weight Regain

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104310
Enrollment
Unknown
Registered
2025-06-15
Start date
2025-06-15
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Morbid Obesity

Interventions

Experimental Group:Received 6 months of lifestyle intervention + 3 months of GVR-100 gastric volume microsphere treatment
Control group:Received 6 months of lifestyle intervention

Sponsors

Qilu Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age range: 16-65 years old; 2. Voluntarily participate in this study, with clear awareness, able to understand and cooperate with lifestyle managers. 3. Patients who have undergone weight loss surgery and meet one of the following conditions: (1) After the patient's weight drops to the lowest point, the% EWL increases by more than 25%, or the BMI increases by more than 5, or the weight increases by more than 10 kg; (2) The patient's% EWL changes from>50% to<50%, or their BMI is greater than 35; (3) After the patient's weight drops to the lowest point, the weight gain is greater than 20% of the maximum preoperative weight loss. (4) After the patient's weight drops to the lowest point, their weight gain exceeds 10% of their preoperative weight

Exclusion criteria

Exclusion criteria: 1.Pregnant or breastfeeding female; 2.Patients refused to sign an informed consent form; 3.Patient had a history of psychiatric illness or severe cognitive impairment; 4.Patients with severe organ dysfunctions who cann't take part in the study;

Design outcomes

Primary

MeasureTime frame
Total weight loss rate over three months;

Secondary

MeasureTime frame
Total weight loss rate over six months;Waist circumference at three and six months;Hip circumference at three and six months;Body Mass Index at Three and Six Months;Blood pressure at three and six months;Fasting blood glucose levels at three and six months;Glycated hemoglobin at three and six months;Insulin resistance index at three and six months;Blood lipid at three and six months;Serum insulin levels at three and six months;Liver function at three and six months;Renal function at three and six months;Uric acid levels at three and six months;

Countries

China

Contacts

Public ContactShaozhuang Liu

Qilu Hospital of Shandong University

liushaozhuang@sdu.edu.cn+86 185 6008 5165

Outcome results

None listed

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