Effects of vitamin D on beta cell function and insulin sensitivity in pre-diabetes and diabetes mellitus type 2 - EVIDENS

Effects of vitamin D on beta cell function and insulin sensitivity in pre-diabetes and diabetes mellitus type 2 - EVIDENS - EVIDENS

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-024487-18-SE

Enrollment

Registered

2011-04-26

Start date

2011-06-20

Completion date

Unknown

Last updated

2020-05-25

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

Conditions

Impaired glucose tolerance, impaired fasting glucose and type 2 diabetes mellitus. Vitamin D deficiency. MedDRA version: 13.1 Level: PT Classification code 10018429 Term: Glucose tolerance impaired System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 13.1 Level: PT Classification code 10056997 Term: Impaired fasting glucose System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 13.1 Level: PT Classification code 10067585 Term: Type 2 dia

Interventions

Trade Name: Vigantol Oil Product Name: Vigantol Oil Pharmaceutical Form: Oral drops, solution INN or Proposed INN: COLECALCIFEROL CAS Number: 67-97-0 Other descriptive name: Vitamin D3 Concentration u

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Informed consent obtained before any trial-related activities. 2. Meeting criteria for IFG, IGT, IFG+IGT or diabetes mellitus at screening. 3. Age 45 - 75 years, female or male. 4. BMI = 32 kg/m2. 5. HbA1c = 7.0 % (MonoS) or = 63 mmol/mol (IFCC) at screening. 6. 25-OH-Vitamin D =65 years) yes F.1.3.1 Number of subjects for this age range 34

Exclusion criteria

Exclusion criteria: 1. Previous participation in this trial. Participation is defined as randomization. 2. Anticipated change in dose of concomitant medication which may interfere with glucose metabolism, such as systemic corticosteroids, non-selective beta-blockers, mono amine oxidase (MAO) inhibitors and anabolic steroids. 3. Treatment with any vitamin D preparation. 4. Regular sun-bathing. 5. Sun-bathing in a southern country for = 1 week within the last 3 months. 6. Hypercalcemia at screening. 7. Hypervitamninosis D at screening. 8. Hyperphosphatemia at screening. 9. Sarcoidosis or other granulomatous disease. 10. Treatment with phenytoin, barbiturates, rifampicin, isoniazid, cardiac glycosides, orlistat or colestyramin. 11. Impaired hepatic function defined as alanine aminotransferase (ALAT) >= three times the upper reference limit. 12. Impaired renal function defined as S-creatinine >133 µmol/L for males and >115 µmol/L for females. 13. Cardiac disease defined as: a. Unstable angina pectoris b. Myocardial infarction within the last 6 months c. Congestive heart failure NYHA class III and IV 14. Cerebral stroke within the last 6 months. 15. Uncontrolled treated/untreated hypertension (systolic blood pressure >= 180 mmHg and/or diastolic blood pressure >= 110mmHg). 16. Known or suspected allergy to trial product or any contraindications to trial product. 17. Cancer (except basal cell skin cancer or squamous cell skin cancer). 18. Anti-diabetic medication of any kind. 19. Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods. 20. Known or suspected abuse of alcohol or narcotics. 21. Mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation. 22. Any other condition that the Investigator and/or Sponsor feel would interfere with trial participation or evaluation of results.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate, in patients with impaired fasting glucose (IFG), impaired glucose tolerance (IGT), IFG+IGT or diet treated type 2 diabetes and vitamin D deficiency, the impact on beta cell function of vitamin D3 treatment.;Secondary Objective: To evaluate, in patients with IFG, IGT, IFG+IGT or diet treated type 2 diabetes and vitamin D deficiency, the impact of vitamin D3 treatment on: ? Change in insulin sensitivity assessed as the ratio of the glucose infusion rate and plasma insulin concentration (M/I) during hyperglycemic clamp. ? Change in glucose tolerance assessed by an oral glucose tolerance test (OGTT). ? Change in fasting plasma glucose and HbA1c. ? Change in CVD risk markers/lipids. ? Change in hormones as leptin, adiponectin and GLP-1. ? Change in 25-OH-vitamin D and PTH. ;Primary end point(s): Placebo-controlled change in beta cell function from baseline after 8 weeks. The plasma insulin response (I) during hyperglycemic clamp will assess beta cell function.;Timepoint(s) of evaluation of this end point: Change from the baseline investigation to the end-of-study investigation after 8 weeks of treatment.	—

Measure

Time frame

Main Objective: To evaluate, in patients with impaired fasting glucose (IFG), impaired glucose tolerance (IGT), IFG+IGT or diet treated type 2 diabetes and vitamin D deficiency, the impact on beta cell function of vitamin D3 treatment.;Secondary Objective: To evaluate, in patients with IFG, IGT, IFG+IGT or diet treated type 2 diabetes and vitamin D deficiency, the impact of vitamin D3 treatment on: ? Change in insulin sensitivity assessed as the ratio of the glucose infusion rate and plasma insulin concentration (M/I) during hyperglycemic clamp. ? Change in glucose tolerance assessed by an oral glucose tolerance test (OGTT). ? Change in fasting plasma glucose and HbA1c. ? Change in CVD risk markers/lipids. ? Change in hormones as leptin, adiponectin and GLP-1. ? Change in 25-OH-vitamin D and PTH. ;Primary end point(s): Placebo-controlled change in beta cell function from baseline after 8 weeks. The plasma insulin response (I) during hyperglycemic clamp will assess beta cell function.;Timepoint(s) of evaluation of this end point: Change from the baseline investigation to the end-of-study investigation after 8 weeks of treatment.

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Secondary

Measure	Time frame
Secondary end point(s): Placebo-controlled change from baseline after 8 weeks in: ? Change in insulin sensitivity assessed as the ratio of the glucose infusion rate and plasma insulin concentration (M/I) during hyperglycemic clamp. ? Change in glucose tolerance assessed by an oral glucose tolerance test (OGTT). ? Change in fasting plasma glucose and HbA1c. ? Change in CVD risk markers/lipids. ? Change in hormones as leptin, adiponectin and GLP-1. ? Change in 25-OH-vitamin D and PTH.;Timepoint(s) of evaluation of this end point: Change from the baseline investigation to the end-of-study investigation after 8 weeks of treatment.	—

Measure

Time frame

Secondary end point(s): Placebo-controlled change from baseline after 8 weeks in: ? Change in insulin sensitivity assessed as the ratio of the glucose infusion rate and plasma insulin concentration (M/I) during hyperglycemic clamp. ? Change in glucose tolerance assessed by an oral glucose tolerance test (OGTT). ? Change in fasting plasma glucose and HbA1c. ? Change in CVD risk markers/lipids. ? Change in hormones as leptin, adiponectin and GLP-1. ? Change in 25-OH-vitamin D and PTH.;Timepoint(s) of evaluation of this end point: Change from the baseline investigation to the end-of-study investigation after 8 weeks of treatment.

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Countries

Sweden

Contacts

Public ContactPI Henrik Wagner, MD

Dpt of Endocrinology, Metabolism and Diabetes

henrik.wagner@karolinska.se+46851779338

Outcome results

None listed

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