Effect of Adjustable Intragastric Balloon in Obese Non-alcoholic Fatty Liver Disease

NCT04182646 | Completed DMC

• 1 other identifier: AIG-G/IGBFLP
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Aims and objectives: The Investigator aimed to evaluate effect of adjustable intra gastric balloon on non-alcoholic fatty liver disease/non alcoholic steatohepatitis (NAFLD/NASH) with or without diabetes mellitus, who have failed to achieve \>10% of total body weight with lifestyle interventions and pharmacotherapy for weight loss. The Investigator will evaluate NASH parameters such as NASH activity score(NAS), liver function tests along with weight loss and change in glycaemic control and changes in hormonal activity. Sample size: Based on previous study, to achieve median reduction of 40% in NAS score with 80% power and 0.05 as type 1 error; total sample size required is 36 cases.

Conditions

Non-Alcoholic Fatty Liver Disease; Non-Alcoholic Steatohepatitis; Obesity; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in NAFLD activity Score

  The 'NAFLD activity score' (NAS) is the most widely used histological grading and staging system for NAFLD. It is a histological scoring system addressing the full spectrum of NAFLD. It includes steatosis, hepatocellular ballooning, lobular inflammation, fibrosis, and the absence of lipogranulomas. In our study, liver histology was assessed by a single pathologist before and after treatment. Steatosis is graded as 0, 1, 2 and 3 depending on steatosis in hepatocytes.Lobular inflammation is graded as 0,1,2 and 3 depending on number of foci of inflammation per 20x field. Hepatocellular ballooning is graded as 0,1 and 2 depending on amount of ballooning. Fibrosis is graded as 0,1,2,3 and 4 depending on level of fibrosis. A composite score is calculated by addition on individual scores from steatosis, hepatocellular ballooning, lobular inflammation and fibrosis.

  6 months

Secondary Outcomes (4)

• Mean Percentage of Total Body Weight Loss (%TBWL) 6 months After Balloon Removal

  6 months

• Change in liver enzymes

  6 months

• Number of Subjects with >= 25% Excess Body Weight Loss at 6 Months

  6 months

• Changes in Glycemic control

  6 months

Study Arms (1)

Single arm

EXPERIMENTAL

The Spatz Adjustable intragastric balloon (AIGB) was developed to extend implantation to 1 year, decrease balloon volume for intolerance and increase volume for diminishing weight loss effect. The concept of an adjustable balloon came from the fact that around 10% of patients are intolerant to the balloon, requiring early extraction and also gastric balloons lose their effectiveness by approximately the 4th month post-implantation, and studies have shown that patients actually regain weight while the balloon is still implanted. AIGB balloon can mitigate this effect by adjustment of balloon volumes as required.

Device: Spartz Balloon

Interventions

Spartz Balloon DEVICE

The Spatz Adjustable intragastric balloon (AIGB) was developed to extend implantation to 1 year, decrease balloon volume for intolerance and increase volume for diminishing weight loss effect. The concept of an adjustable balloon came from the fact that around 10% of patients are intolerant to the balloon, requiring early extraction and also gastric balloons lose their effectiveness by approximately the 4th month post-implantation, and studies have shown that patients actually regain weight while the balloon is still implanted. AIGB balloon can mitigate this effect by adjustment of balloon volumes as required

Single arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants (age 18- 65) diagnosed to have NAFLD / NASH as per imaging and histological criteria of American Association for Study of Liver Diseases (AASLD) with or without Diabetes Mellitus and who have failed the non-invasive approach to weight loss within the last 6 months. This would include patients who have failed to lose at least 10% of their base weight with dietary and lifestyle changes along with pharmacotherapy.
• Patients with BMI \> 27.5 kg/m2 who are unable to tolerate exercise program for weight loss.
• Patients with BMI \> 32.5 Kg/m2 who have NAFLD / NASH but are not willing for bariatric surgery.

You may not qualify if:

• Previous history of gastric or bariatric surgery
• Current or recent (within 6 months) gastric or duodenal ulcers
• Cirrhosis patients with clinically significant portal hypertension defined as Hepatic Venous Pressure Gradient (HVPG) \> 12 or recent variceal or Portal hypertensive gastropathy related bleed within the last 3 months
• Presence of inflammatory disease of the gastrointestinal tract including esophagitis, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease.
• A large hiatal hernia or \>5 cm hernia or ≤5 cm with associated severe or intractable gastro-esophageal reflux symptoms.
• Achalasia or any other severe motility disorder that may pose a safety risk during removal of the device.
• Any gastric space occupying lesions including polyps,
• Patients who are known to have or suspected to have an allergic reaction to materials contained in Adjustable balloon.
• Psychologically unstable patients or patients with known psychiatric illness.
• Patients unwilling to participate in an established medically-supervised diet and behaviour modification program, with routine medical follow-up.
• Patients receiving aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants, not under medical supervision.

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

Study Sites (1)

Asian Institute of Gastroenterology Hospital

Hyderabad, Telangana, 500082, India

Location

Related Publications (1)

• Kalapala R, Jagtap N, Rughwani H, Asif S, Sekaran A, Sharma M, Kulkarni A, Rao PN, Tyagi A, Reddy DN. Adjustable Intragastric Balloon for Metabolic Dysfunction-associated Steatotic Liver Disease-Enhanced Weight Loss and Histological Improvement. J Clin Exp Hepatol. 2025 Nov-Dec;15(6):103152. doi: 10.1016/j.jceh.2025.103152. Epub 2025 Aug 12.

  PMID: 40969863 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Rakesh Kalapala, DNB

  Asian Institute of Gastroenterology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Gastroenterologist

Model Details: The Spatz Adjustable intragastric balloon (AIGB) was developed to extend implantation to 1 year which have capability for decrease balloon volume for intolerance and increase volume for diminishing weight loss effect. The concept of an adjustable balloon came from the fact that around 10% of patients are intolerant to the balloon, requiring early extraction and also gastric balloons lose their effectiveness by approximately the 4th month post-implantation, and studies have shown that patients actually regain weight while the balloon is still implanted. AIGB balloon can mitigate this effect by adjustment of balloon volumes as required

Study Record Dates

• First Submitted: August 3, 2019
• First Posted: December 2, 2019
• Study Start: February 25, 2022
• Primary Completion: April 20, 2023
• Study Completion: October 4, 2023
• Last Updated: August 1, 2025

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)