Effect of NF-кB Dependent Proinflammation on Osteogenic Differentiation of the Mesenchymal Stem Cells in Type 2 Diabetes

NCT02286128 | Completed

• 1 other identifier: ChiangMaiU
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This study determines whether NF-кB dependent proinflammatory state found in type 2 diabetes yield to a higher RAGE activation in the mesenchymal stem cell, as well as the effects of the proinflammation on osteoblast differentiation impairment and cellular apoptosis in type 2 diabetic patients. This study will compare non-diabetic control subjects and type 2 diabetic patients with metformin monotherapy failure in the aspect of 1) serum markers for NF-кB dependent proinflammatory state and its intracellular signals, 2) osteogenic differentiation and apoptosis of the mesenchymal stem cells, and 3) serum AGE, RAGE and cellular RAGE activation.

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes; RAGE; osteoblast

Outcome Measures

Primary Outcomes (1)

• Correlation between NF-кB dependent-proinflammation markers and osteoblast-specific gene expression in the MSC to measure the effects of NF-кB dependent-proinflammation on differentiation potential toward osteoblast in type 2 diabetes.

  2-4 weeks

Secondary Outcomes (2)

• Correlation between NF-кB dependent-proinflammation markers and apoptotic marker expression in the MSC to measure effects of NF-кB dependent-proinflammation on cellular apoptosis in type 2 diabetes.

  2-4 weeks

• Correlation between NF-кB dependent-proinflammation markers and the expression of RAGE and its downstream signals in the MSC to measure effects of NF-кB dependent-proinflammation on cellular RAGE activation in type 2 diabetes.

  2-4 weeks

Study Arms (2)

Non-diabetic controls

Age-matched non-diabetic subjects

Type 2 diabetes

Type 2 diabetes with metformin monotherapy failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will include 30 non-diabetic control subjects, and 45 type 2 diabetic patients who has HbA1c higher than 6.5% with metformin monotherapy.

You may qualify if:

• Patients with type 2 diabetes who has HbA1c higher than 6.5% with metformin monotherapy and age-matched non-diabetes control subjects who signed consent form to be in the study.

You may not qualify if:

• Patients who use thiazolidinedione, steroid, immunosuppressive medications, antiresorptive agents or anabolic therapy for osteoporosis.
• Patients with elevated serum creatinine higher than 1.4 in female and 1.5 in male.
• Patients with metastases cancer or hematologic malignancy.

Sponsors & Collaborators

• Chiang Mai University: lead

Study Sites (1)

Mattabhorn Phornputkul

Chiang Mai, 50200, Thailand

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and RNA (from peripheral blood-derived mesenchymal stem cells)

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• Mattabhorn Phornphutkul, M.D, Ph.D

  Chiang Mai University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 28, 2014
• First Posted: November 7, 2014
• Study Start: November 1, 2014
• Primary Completion: May 3, 2018
• Study Completion: May 3, 2018
• Last Updated: July 12, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)