Effect of Escalating Oral Vitamin D Replacement on HOMA-IR in Vitamin D Deficient Type 2 Diabetics

NCT04183257 | Completed Phase 4 DMC

• 1 other identifier: to be ascertained
• Study Type: interventional
• Target: 106
• Locations: 0 countries
• Sites: N/A

Brief Summary

In addition to its effect on maintaining calcium homeostasis and mineralization of bone, vitamin D has been linked to play a pivotal role in different medical conditions including type 2 diabetes mellitus. Vitamin D plays a major role in both insulin secretion and decreasing the insulin resistance hence has a major impact on glucose tolerance. This study is designed to determine the non-skeletal effects of vitamin D in improving the glucose tolerance in type 2 diabetic patients by decreasing the insulin resistance

Conditions

Vitamin D Deficiency; Insulin Resistance; Diabetes Mellitus, Type 2

Keywords

Vitamin D; T2DM; Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• Homeostatic Model Assessment of Insulin Resistance

  insulin resistance reduction to \<2.5

  3 months

Secondary Outcomes (1)

• Glycated Hemoglobin (HbA1C)

  3 months

Study Arms (2)

vitamin D

EXPERIMENTAL

vitamin D arm will receive oral vitamin D in escalating dosage.

Drug: oral vitamin D

Conventional

NO INTERVENTION

This arm will receive conventional treatment only.

Interventions

oral vitamin D DRUG

oral Vitamin D 400IU will be given and will be escalated every 2 weeks.

Also known as: oral vitamin D 400IU

vitamin D

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Both genders
• Age 25 to 50 years as type 2 diabetes usually diagnosed in this age range.
• Patients having Type 2 Diabetes Mellitus
• Taking oral antidiabetic medicines
• Serum 25(OH) vitamin D levels below 20ng/ml having no clinical symptoms of vitamin D deficiency.
• HOMA-IR \> 2.5

You may not qualify if:

• Patients having evidence of liver dysfunction and chronic renal insufficiency because it will alter the metabolism of cholecalciferol.
• Patients having parathyroid dysfunction diagnosed on the basis of blood tests as replacement of vitamin D in these patients is very complex.
• Patients having gastrointestinal surgeries that will alter the absorption of cholecalciferol diagnosed from detailed clinical history and clinical examination.
• Patients having clinical features of gastroparesis diagnosed on the basis of clinical history as it can alter the absorption of vitamin D.
• Patients having erratic control of diabetes requiring multiple hospital admissions for diabetic emergencies.
• Pregnant and lactating mothers.

Sponsors & Collaborators

• King Edward Medical University: lead

MeSH Terms

Conditions

Vitamin D Deficiency; Insulin Resistance; Diabetes Mellitus, Type 2

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Endocrinology

Study Record Dates

• First Submitted: September 7, 2015
• First Posted: December 3, 2019
• Study Start: September 30, 2016
• Primary Completion: April 30, 2017
• Study Completion: July 30, 2017
• Last Updated: December 3, 2019

Record last verified: 2019-12