Incretin mediation on microbiome, metainflammation and adipose tissue plasticity. Functional study in an obese cohort after a dietary intervention

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12973246

Enrollment

Registered

2020-10-01

Start date

2016-06-01

Completion date

Unknown

Last updated

2021-12-21

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

Conditions

Relationship between hormones that decrease blood glucose and the resident bacterial content of the intestine Digestive System

Interventions

Equal numbers of non-morbidly obese and age-matched healthy controls will be recruited. All participants will be prescribed a six-month low-calorie Mediterranean type Diet (20 Kcal/Kg

101kcal/100ml, of which 54% are carbohydrates, 16% proteins and 30% lipids). Extraction at 0, 15, 30, 60 and 120min. Determination of plasma concentrations of glucose, insulin, GLP-1, GLP-2.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.1. Obese group: Non-morbid obese subjects with a body mass index (BMI) range =30 to =40 kg/m² 1.2. Control group: 2. Aged >18 and <65 years 3. Absence of acute or chronic systemic disease (other than obesity) 4. Absence of any pharmacological treatment and weight stability at least during the 3 previous months before entry in the study 5. Informed consent signed 6. BMI range =18 to =25 kg/m²

Exclusion criteria

Exclusion criteria: Both groups: 1. Active smokers 2. Alcohol intake >40gr/day 3. Presence of other cardiovascular risk factors except obesity (arterial hypertension, dyslipidemia, diabetes mellitus or history of disease cardiovascular disease) 4. Moderate-severe chronic liver disease or chronic renal failure 5. Chronic inflammatory diseases 6. Surgery or recent hospital admission (<3 months) 7. Glucocorticoid treatment in the last 6 months 8. Neoplasia in the previous 5 years 9. Pregnancy or lactation

Design outcomes

Primary

Measure	Time frame
Measured at every visit at baseline and every month until the end of the study: 1. Bodyweight (kg) 2. Height (m) 3. Waist circumference (cm) 4. Blood pressure (mmHg) At baseline and 6 month follow up: 5. Meal Tolerance Test (MTT) (blood will be taken before meal ingestion (time 0 min) and at 15, 30, 60, and 120 min after meal ingestion) 5.1. GLP-1 and GLP-2 assessed using ELISA methods 5.2. Glucose, cholesterol, and triglycerides determined using standard enzymatic methods 5.3. Plasma insulin analyzed by immunoassay 6. A study of the intestinal microbiome-related with the incretin response will be determined using shotgun sequencing of stool DNA for whole metagenome analysis	—

Measure

Time frame

Measured at every visit at baseline and every month until the end of the study: 1. Bodyweight (kg) 2. Height (m) 3. Waist circumference (cm) 4. Blood pressure (mmHg) At baseline and 6 month follow up: 5. Meal Tolerance Test (MTT) (blood will be taken before meal ingestion (time 0 min) and at 15, 30, 60, and 120 min after meal ingestion) 5.1. GLP-1 and GLP-2 assessed using ELISA methods 5.2. Glucose, cholesterol, and triglycerides determined using standard enzymatic methods 5.3. Plasma insulin analyzed by immunoassay 6. A study of the intestinal microbiome-related with the incretin response will be determined using shotgun sequencing of stool DNA for whole metagenome analysis

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

Spain

Outcome results

None listed

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