Double-Blind, Placebo-Controlled, Randomised Multicentre Pilot Study to Investigate the Benefit and Tolerability of Tetrahydroxylated Bile Acid to Maintain Normal Blood Glucose Levels in Pre-diabetic Subjects
- Conditions
- elevated HbA1c level (prediabetes)R73.0Abnormal glucose tolerance test
- Registration Number
- DRKS00013189
- Lead Sponsor
- Glycemicon AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 83
1. 30–65 years
2. BMI of 23.0 to 34.9 kg/m2
3. HbA1c 5.7-6.4% at V1
4. Willingness to maintain the usual daily food consumption during study duration
5. Willingness to maintain the usual level of physical activity (incl. sport) during study duration
6. Willingness to accept the required blood draws
7. Stable concomitant medications (if any) for at least last 3 months prior to V1
8. Stable body weight (=3 kg difference) for the last 3 months prior to V1
9. Subject’s agreement to comply with study procedures
10. Women of childbearing potential:
- negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1
- commitment to use contraception methods during the study
Prerequisite for the participation in the study is a written informed consent by the participant following written and oral information by the investigator regarding nature, purpose, possible benefit and possible risks of the clinical study.
1. Previously known sensitivity to the components of the investigational product
2. Previously known severe diseases such as chronic liver disease, heart, lung or kidney disease
3. Pathological electrocardiogram (ECG) according to investigator’s judgment
4. Active malignant disease within the last 5 years before V1
5. Acute or chronic psychotic disorders
6. Previously known severe acute or chronic immunological disorders such as AIDS (or HIV positive)
7. Severe acute or chronic infection
8. Digestion/absorption disorders in gastrointestinal (GI) tract (e.g. inflammatory bowel disease)
9. Eating disorder
10. Uncontrolled thyroid disorder
11. Uncontrolled hypertension (regularly >140/90 mmHg)
12. Blood transfusion within the last 12 weeks before V1
13. Blood donation within the last 6 months before V1
14. Preceding surgery of the intestine affecting the GI tract function according to investigator’s judgment
15. Previously known cholezystolithiasis (except for gallbladder surgery that took place earlier than in the last 12 months before V1)
16. Acute or chronic pancreatitis
17. Clinical symptoms of diabetes
18. Previously known hemoglobinopathy (HbS, HbC, HbD, HbH, HbF or HbE)
19. Anemia (Hb =11 g/dL)
20. Deviations in laboratory values at V1, except for Hb or HbA1c that is:
- clinically significant or
- >2x upper limit of normal, unless the deviation is justified by a previously known not clinically relevant condition (e.g. Gilbert's syndrome)
21. Anti-diabetic therapy or use of drugs and/or supplements, for reduction of blood glucose levels within the last 4 weeks before V1 and throughout the study
22. Change in daily dose of any treatment and/or use of supplements with a possible impact on glycemic control in the last 3 months prior to V1 and throughout the study
23. Intake of bile acid binders (e.g. fiber supplements)
24. History of abuse of drugs, alcohol or medication in the last 6 months prior to V1
25. Inability to comply with study procedures (e.g. due to language difficulties etc.)
26. Participation in other clinical studies within the last 4 weeks prior to V1 or during the study
27. Recent change in diet and lifestyle (within the last 4 weeks prior to V1)
28. Women of child bearing potential: pregnant or breast-feeding
29. Any other reason deemed suitable for exclusion, per investigator’s judgment
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HbA1c at V3, V4 and V5, each compared to V2<br><br>Visit plan:<br>visit 2 = baseline / randomization<br>visit 3 = control, 8 weeks after V2<br>visit 4 = control, 16 weeks after V2<br>visit 5 = termination, 24 weeks after V2
- Secondary Outcome Measures
Name Time Method - FPG (Fasting blood glucose) at V3, V4 and V5, each compared to V2<br>- oGTT (oral glucose tolerance test) at V3, V4 and V5, each compared to V2<br>- Insulin and C-peptide at V3, V4 and V5, each compared to V2<br>- HOMA (Homeostasis Model Assessment) - indices at V3, V4 and V5, each compared to V2<br>- Fructosamine at V3, V4 and V5, each compared to V2<br>- Fat parameters in blood: FFA and VLDL at V3, V4 and V5, each compared to V2<br>- Body weight with fat content and fat-free mass at V3, V4 and V5, each compared to V2 <br>- Waist circumference at V3, V4 and V5, each compared to V2<br>- Fat biopsy (in the subgroup of subjects who consent to the procedure) at V5, compared to V2<br>- Global evaluation of benefit by subjects & investigator at V5