Acute Microbial Switch

Not Applicable

Recruiting

• Conditions: Insulin Sensitivity; Glucose Metabolism Disorders (Including Diabetes Mellitus); Hyperinsulinism

• Registration Number: NCT05764200
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-2-17
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - Lean normoglycemic individuals:<br><br> - Lean (BMI = 18.5 kg/m2 and = 24.9 kg/m2 );<br><br> - Normal fasting glucose (plasma glucose < 5.6 mmol/L) and a HOMA-IR< 2.2<br><br>Individuals with overweight/obesity and prediabetes/insulin resistance:<br><br> - Overweight/obesity (BMI = 28 kg/m2 and = 40 kg/m2 );<br><br> - insulin resistance (HOMA-IR>2.2) and/or impaired fasting glucose (IFG: plasma<br> glucose = 5.6 mmol/l)<br><br>For both subject groups:<br><br> - Aged 30 - 75 years;<br><br> - Normal blood pressure (systolic blood pressure 100-150mmHg, diastolic blood pressure<br> 60-100 mmHg);<br><br> - Weight stable for at least 3 months (± 2 kg)<br><br>Exclusion Criteria:<br><br> - T2DM (defined as fasting plasma glucose = 7.0 mmol/L)<br><br> - Gastroenterological diseases<br><br> - Abdominal surgery affecting the GI tract;<br><br> - Cardiovascular diseases, cancer, liver or kidney malfunction, disease with a life<br> expectancy shorter than five years;<br><br> - Abuse of products;<br><br> - Alcohol (> 15 standard units per week)<br><br> - Drugs<br><br> - Excessive nicotine use defined as >20 cigarettes per day;<br><br> - Plans to lose weight or following of a hypocaloric diet<br><br> - Regular supplementation of pre- or probiotic products, use of pre- or probiotics<br> three months prior to the start of the study;<br><br> - Intensive exercise training more than three hours a week;<br><br> - Use of most medications that influence glucose or fat metabolism, like some lipid<br> lowering-drugs (e.g., PPAR ? or PPARa (fibrates) agonists), glucose-lowering agents<br> (including all sulfonylureas, biguanides, a-glucosidase inhibitors,<br> thiazolidinediones, repaglinide, nateglinide and insulin), inflammation (e.g.,<br> anti-inflammatory* or immunosuppressive drugs) and anti-oxidants;<br><br> - Regular use of laxatives;<br><br> - Use of antibiotics in the last three months (antibiotics use can alter substantially<br> the gut microbiota composition).<br><br> - Veganism<br><br> - Lactose intolerance<br><br> - For women: pregnancy or lactation

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
24 hour intestinal gas concentrations

Secondary Outcome Measures

Name	Time	Method
24 hour energy expenditure;24 hour substrate metabolism;fecal microbial metabolite concentrations;Fecal microbiota composition;24 hour glucose monitoring;circulating blood markers;Urine metabolites