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Prevention study for Type 2 Diabetes
Official title Butyrate-enriched Triglyceride and Diabetes Prevention
ClinicalTrials.gov ID: NCT06384313
What this study is testing
- What it's testing
- A body of animal studies as well as observational studies in humans demonstrated that butyrate is one SCFA that has pronounced positive effects on body weight control, inflammation, and insulin resistance. Even though the SCFA hexanoate is less researched, it has been shown to be involved in anti-inflammatory processes.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 70. Healthy volunteers may be eligible.
You may be able to join if
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Age 20-70 years
- BMI ≥ 28 and \< 40 kg/m2
- Weight stable for at least 3 months
- Normal blood pressure (systolic blood pressure 100-140 mmHg, diastolic blood pressure 60-90 mmHg)
You likely can't join if
- Diabetes mellitus (type 1 or 2)
- Cardiovascular disease: including no history or myocardial infarction, heart failure, arrhythmias
- Pulmonary disease: no history of chronic obstructive pulmonary disease, emphysema, bronchitis, asthma
- Kidney (e.g. kidney failure) or liver (e.g. cirrhosis, non-alcoholic fatty acid) malfunction
- Gastrointestinal disease (no inflammatory bowel disease, irritable bowel syndrome or digestive disorders) or a history of abdominal surgery (except...
- Autoimmune disease
See the full eligibility criteria
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Age 20-70 years
- BMI ≥ 28 and \< 40 kg/m2
- Weight stable for at least 3 months
- Normal blood pressure (systolic blood pressure 100-140 mmHg, diastolic blood pressure 60-90 mmHg)
- One or more of the following criteria to determine disturbed glucose/insulin homeostasis
- Fasting glucose 5.6-6.9 mmol/L
- Two-hour glucose of 7.8-11.1 mmol/L
- HOMA-IR ≥ 2.2
- HbA1c (5.7-6.4%)
- Diabetes mellitus (type 1 or 2)
- Cardiovascular disease: including no history or myocardial infarction, heart failure, arrhythmias
- Pulmonary disease: no history of chronic obstructive pulmonary disease, emphysema, bronchitis, asthma
- Kidney (e.g. kidney failure) or liver (e.g. cirrhosis, non-alcoholic fatty acid) malfunction
- Gastrointestinal disease (no inflammatory bowel disease, irritable bowel syndrome or digestive disorders) or a history of abdominal surgery (except appendectomy and cholecystectomy)
- Autoimmune disease
- Any other diseases affecting glucose and/or lipid metabolism or use of any medication that influence glucose or fat metabolism and inflammation
- Ongoing disease or any disease with a life expectancy ≤ 5 years
- Abuse of products; alcohol (\>15 units per week) and drugs, excessive nicotine use defined as \>20 cigarettes per week
- Regular supplementation of pre- or probiotic products, use of pre- or probiotics, antibiotics and laxatives 3 months prior to the start of the study
- Intensive exercise training more than three hours a week
- Plan to lose weight or to follow a hypocaloric diet or vegetarian diet
- Pregnancy
The study team makes the final eligibility decision.
Where it's taking place
- Maastricht, Limburg, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Maastricht, Limburg, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.