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Characterization of the incretin response and microbiota following bariatric surgery, and its role for weight loss – a search for polytherapeutic strategies to combat obesity and ultimately rival surgery

Characterization of the incretin response and microbiota in women before an after bariatric surgery, aiming to determine how the microbiota regulates metabolism, and its role for weight loss: a randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11764561
Enrollment
30
Registered
2017-04-03
Start date
2017-02-27
Completion date
Unknown
Last updated
2019-03-25

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

Conditions

Obesity Nutritional, Metabolic, Endocrine Obesity

Interventions

Non-diabetic patients with severe obesity (that is, BMI >40 kg/m. or BMI >35 kg/m. with comorbidities) will be randomized into two groups receiving either gastric bypass (RYGB) or gastric sleeve. Pati

Sponsors

Södertälje Sjukhus
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Obese non-diabetic females 2. 18-65 years of age 3. Signed informed consent form

Exclusion criteria

Exclusion criteria: 1. Type 2 diabetes 2. Any history of receiving GLP-1 analogues or DPP-4 inhibitors 3. Previous treatment with insulin (any regimen) within 3 months 4. Current or history of drug and alcohol abuse

Design outcomes

Primary

MeasureTime frame
1. Plasma GLP-1, measured using the meal tolerance test and GLP-1 specific ELISA of serum samples 2. Gut microbiota composition, analyzed from fecal samples Timepoints: before 10-day diet, after 10-day diet/before surgery, 3 months after surgery, 6 months after surgery

Secondary

MeasureTime frame
1. Plasma inflammatory markers, analyzed by specific ELISAs 2. Lipid profile, determined by commercially available HDL and LDL/VLDL Cholesterol Assay Kits, Free Fatty Acid Quantification Kit, as well as Triglyceride Quantification Kit Timepoints: before 10-day diet, after 10-day diet/before surgery, 3 months after surgery, 6 months after surgery

Countries

Sweden

Outcome results

None listed

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