7-Ketolithocholic Acid for people with prediabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study evaluates the safety and potential glucose-lowering effect of 7-Ketolithocholic Acid (7-KLCA) when combined with a structured diet and physical activity program in adults with prediabetes. Participants receive either 7-KLCA or placebo, alongside a predefined low-glycemic, hypocaloric diet and encouraged physical activity, with measurements focused on fasting plasma glucose and other metabolic parameters such as HbA1c. The trial will monitor safety and tolerability, while assessing changes in metabolic markers over the study period. If a meaningful glucose-lowering effect is observed, 7-KLCA could be considered as an early intervention strategy to prevent or delay type 2 diabetes onset.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male and female participants aged ≥18 years and ≤70 years.
2. Ability and willingness to provide written informed consent.
3. Diagnosis of prediabetes, defined by the following metabolic criteria:

   * Impaired fasting glucose (IFG): fasting plasma glucose levels between 100 and 125 mg/dL.
   * Impaired glucose tolerance (IGT): plasma glucose levels between 140 and 199 mg/dL measured 2 hours after a standard oral glucose tolerance test (OGTT).
   * Elevated HbA1c: HbA1c values between 5.7% and 6.4% (or 42 and 47 mmol/mol).
4. Body mass index (BMI) in the range 25-31 kg/m2 (inclusive).
5. Willingness to strictly comply with a low-glycaemic, hypocaloric diet during the study period and maintain a food diary.
6. Willingness to comply with recommended physical activity during the study period and maintain an activity diary.
7. Women of childbearing potential must agree to not become pregnant during the study and to use effective contraception (according to Recommendations related to contraception and pregnancy testing in clinical trials.

Exclusion Criteria:

1. Previous or current diagnosis of diabetes mellitus.
2. Presence of hypertension, defined as blood pressure \>130/85 mmHg.
3. Hypertriglyceridemia, defined as fasting blood triglyceride levels ≥ 200 mg/dL.
4. LDL cholesterol ≥ 190 mg/dL.
5. Current treatment with oral hypoglycaemic agents or use of supplements with hypoglycaemic effects.
6. Use of any medication (self-medication or prescription medication) or supplementation potentially acting on glucose and lipid parameters within 28 days before entry in the study (or at least 5 times the respective elimination half-life, whichever is longer).
7. Any medical condition or treatment that, in the opinion of the investigator, could interfere with the study outcomes or participant safety.
8. Use of vitamin K antagonist anticoagulant drugs (such as warfarin).
9. Pregnancy or breast-feeding.
10. Any other condition that would preclude adherence to the study protocol or informed consent process, including, but not limited, to active or uncontrolled metabolic, endocrine, cardiovascular, renal, hepatic, pulmonary, gastrointestinal, neurological, endocrinological, immunological, or psychiatric disease.
11. Subjects with any history of hypersensitivity to the product under study or its excipients (please refer to Appendix B for listing of ingredients).

Where it's running

• Studio Medico, Piazza Eroi della Libertà, 7
  Bordighera, Italy Recruiting
• Studio Medico, Via Roma, 46
  Ospedaletti, Italy Recruiting
• Studio Medico, Via Elba 21
  San Bartolomeo al Mare, Italy Recruiting
• Studio Medico, Corso Imperatrice 5
  Sanremo, Italy Recruiting
• Studio Medico, Corso Imperatrice 5
  Sanremo, Italy Recruiting
• Studio Medico, Corso Matuzia 13
  Sanremo, Italy Recruiting

Study contacts

• Study coordinator: Dr. Riccardo Agati
• Email: riccardo.agati@gmail.com
• Phone: +33 (0)184636817

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.