Can Vitamin D Supplementation Prevent Type 2 Diabetes?

NCT02112721 | Completed Phase 4

• 1 other identifier: 1047897
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine whether vitamin D supplementation in overweight/obese individuals with vitamin D deficiency can improve insulin secretion and/or insulin resistance by decreasing subclinical inflammation. Results of the present study may help to identify new strategies to prevent type 2 diabetes in high-risk groups (i.e. overweight and obese individuals, and individuals with a strong family history of diabetes). Hypothesis: That increasing plasma 25(OH)D concentrations in healthy individuals at risk for type 2 diabetes with low vitamin D levels through vitamin D supplementation, will improve insulin sensitivity and also insulin secretion by reducing the underlying sub-clinical chronic inflammation. Aims: To establish whether 16-week vitamin D supplementation given to healthy individuals with low vitamin D levels will:

1. 1.improve insulin sensitivity (in vivo and tissue) and/or insulin secretory function
2. 2.determine whether this relationship is mediated by a reduced chronic inflammation

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• Initial Insulin Sensitivity Measure using Euglycaemic glucose clamp

  The clamp will be used to measure insulin sensitivity. The clamp is initiated by an intravenous bolus injection of insulin (9milliUnit/kg). Insulin is then constantly infused at a rate of 40 milliUnit.m-2.min-1 for 120 min into an arm vein, whilst glucose is variably infused to maintain euglycaemia. Plasma glucose values will be monitored every 5 minutes during the clamp and the variable infusion rate of glucose is adjusted to maintain blood glucose at a constant value of 5mmol/L.

  Week 1

• Follow up Insulin Sensitivity Measure using Euglycaemic glucose clamp

  The clamp will be used to measure insulin sensitivity. The clamp is initiated by an intravenous bolus injection of insulin (9milliUnit/kg). Insulin is then constantly infused at a rate of 40 milliUnit.m-2.min-1 for 120 min into an arm vein, whilst glucose is variably infused to maintain euglycaemia. Plasma glucose values will be monitored every 5 minutes during the clamp and the variable infusion rate of glucose is adjusted to maintain blood glucose at a constant value of 5mmol/L.

  Week 17

Secondary Outcomes (8)

• Initial measurement of inflammatory markers

  Week 1

• Follow Up Measurement of inflammatory markers

  Week 17

• Initial Measure of Adiposity (DEXA)

  Week 1

• Follow Up Measure of Adiposity (DEXA)

  Week 17

• Initial Oral Glucose Tolerance Test - OGTT

  Week 1

Other Outcomes (10)

• Initial - Other Tissue Analyses

  Week 1

• Follow Up- Other Tissue Analyses

  Week 17

• Resting systolic and diastolic blood pressure

  Week 1

Study Arms (2)

Vitamin D Group

EXPERIMENTAL

Each participant will be given an initial stat dose of 2500 μg (100,000 IU) of Ostelin (Reckitt Benckiser). Thereafter, participants will take 100 μg/day (4,000 IU, 4 tablets) Ostelin daily for a period of 16 weeks.

Dietary Supplement: Vitamin D

Placebo group

PLACEBO COMPARATOR

Each participant will be given an equivalent number of placebo tablets

Dietary Supplement: Placebo

Interventions

Vitamin D DIETARY_SUPPLEMENT

Also known as: Ostellin

Vitamin D Group

Placebo DIETARY_SUPPLEMENT

Placebo group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age \>18 or \<60 years,
• (OH)D \< 50 nmol/L
• Weight change \< 5 kg in last 12 months
• BMI \>25kg/m2 but weight \<159kg due to DEXA scan restrictions
• Non-diabetic, no allergy, non-smoker, no high alcohol use
• No current intake of medications including vitamin supplements
• No kidney, cardiovascular, haematological, respiratory, gastrointestinal, endocrine or central nervous system disease, as well as no psychiatric disorders, no active cancer within the last five years; no presence of acute inflammation (by history, physical or laboratory examination)
• Not menopausal, pregnanct or lactating

You may not qualify if:

• Age \<18 or \> 60 years
• (OH)D \> 50 nmol/L
• Weight change \> 5 kg in last 12 months
• Diabetes (diagnosed or oral glucose tolerance test (OGTT), hypercalcaemia, allergy
• Current smoking habit, high alcohol use
• Current intake of medications including vitamin supplements
• Kidney, cardiovascular, haematological, respiratory, gastrointestinal, endocrine or central nervous system disease, as well as psychiatric disorder, active cancer within the last five years; presence of acute inflammation (by history, physical or laboratory examination)
• Menopause, pregnancy or lactation

Sponsors & Collaborators

• Monash University: lead
• University of Victoria: collaborator
• University of Auckland, New Zealand: collaborator

Study Sites (1)

Monash Centre for Health Research and Implementation

Melbourne, Victoria, 3168, Australia

Location

Related Publications (5)

• Stark R, Feehan J, Mousa A, Andrews ZB, de Courten B. Liver-expressed antimicrobial peptide 2 is associated with improved pancreatic insulin secretion in adults with overweight and obesity. Diabetes Obes Metab. 2023 May;25(5):1213-1220. doi: 10.1111/dom.14968. Epub 2023 Jan 19.

  PMID: 36597795 DERIVED

• Mousa A, Naderpoor N, Wilson K, Plebanski M, de Courten MPJ, Scragg R, de Courten B. Vitamin D supplementation increases adipokine concentrations in overweight or obese adults. Eur J Nutr. 2020 Feb;59(1):195-204. doi: 10.1007/s00394-019-01899-5. Epub 2019 Jan 16.

  PMID: 30649593 DERIVED

• Scott D, Mousa A, Naderpoor N, de Courten MPJ, Scragg R, de Courten B. Vitamin D supplementation improves waist-to-hip ratio and fasting blood glucose in vitamin D deficient, overweight or obese Asians: A pilot secondary analysis of a randomised controlled trial. J Steroid Biochem Mol Biol. 2019 Feb;186:136-141. doi: 10.1016/j.jsbmb.2018.10.006. Epub 2018 Oct 12.

  PMID: 30321667 DERIVED

• Mousa A, Naderpoor N, de Courten MP, Teede H, Kellow N, Walker K, Scragg R, de Courten B. Vitamin D supplementation has no effect on insulin sensitivity or secretion in vitamin D-deficient, overweight or obese adults: a randomized placebo-controlled trial. Am J Clin Nutr. 2017 Jun;105(6):1372-1381. doi: 10.3945/ajcn.117.152736. Epub 2017 May 10.

  PMID: 28490514 DERIVED

• de Courten B, Mousa A, Naderpoor N, Teede H, de Courten MP, Scragg R. Vitamin D supplementation for the prevention of type 2 diabetes in overweight adults: study protocol for a randomized controlled trial. Trials. 2015 Aug 7;16:335. doi: 10.1186/s13063-015-0851-6.

  PMID: 26246241 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Barbora de Courten, PhD, MD

  Monash University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 10, 2014
• First Posted: April 14, 2014
• Study Start: May 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: November 1, 2016
• Last Updated: December 8, 2016

Record last verified: 2016-12

Locations

AU (1)