Glucose IV and its Hepatic outcomes After a metabolic Stress Test during bariatric surgery in obese patients with and without MASLD (GHAST study).

Glucose IV and its Hepatic outcomes After a metabolic Stress Test during bariatric surgery in obese patients with and without MASLD (GHAST study). - GHAST study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON57796

Enrollment

Registered

2025-01-23

Start date

2025-11-11

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

Metabolic dysfunction-associated steatotic liver disease (MASLD) Fatty liver disease

Interventions

During bariatric surgery, all participants will receive a 35-grams intravenous glucose bolus test (IVGTT) consisting of labeled glucose in 140cc (production by A15 pharmacy). Liver biopsies will be

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Non-MASLD group: Adults aged 35-65 years. Scheduled for Roux-en-Y gastric bypass (RYGB) bariatric surgery. BMI >= 40 kg/m² or >= 35 kg/m² with obesity-related comorbidities. Ability to provide informed consent. For MASLD group: Confirmed diagnosis of MASLD by FibroScan. Stable weight (no more than 3% total weight loss) from screening to surgery. Ability to provide informed consent.

Exclusion criteria

Exclusion criteria: Use of GLP-1 receptor agonists. Primary lipid disorders or genetic insulin resistance. Uncontrolled hypertension (RR > 150/95 mmHg). Chronic kidney disease (creatinine > 150 µmol/L). Pregnancy or breastfeeding. Significant systemic or major illnesses other than obesity-related diseases. Type 1 or type 2 diabetes. Coagulation disorders or anticoagulant use. Contraindication for liver biopsy. History of cardiac dysrhythmias or cardiovascular events.

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the change in (single cell) RNA seq based hepatic gene expression pre- and 45 min post-glucose administration in relation to amount of hepatic steatosis (fibroscan validated by paraffin embedded histology of liver biopsy).	—

Secondary

Measure	Time frame
Secondary endpoints include (single cell) RNA seq based transcriptomic changes in various adipose tissue depots as well as in the baseline (bulk) RNA seq based transcriptome of small intestinal jejunal tissue in which also gut microbiota composition will be analysed. Finally, also changes in plasma metabolite products degradation product of (labeled) glucose catabolism, untargeted plasma metabolomics and proteomics will be performed at both timepoints.	—

Measure

Time frame

Secondary endpoints include (single cell) RNA seq based transcriptomic changes in various adipose tissue depots as well as in the baseline (bulk) RNA seq based transcriptome of small intestinal jejunal tissue in which also gut microbiota composition will be analysed. Finally, also changes in plasma metabolite products degradation product of (labeled) glucose catabolism, untargeted plasma metabolomics and proteomics will be performed at both timepoints.

—

Countries

Netherlands

Contacts

Public ContactD.P. Baars

Amsterdam UMC

d.p.baars@amsterdamumc.nl+31650409421

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 29, 2026