Genetic Contribution to the Pathophysiology of the Charcot Foot in Qatari Patients With Diabetes

NCT02316483 | Completed DMC

• 1 other identifier: 13-00031 [JIRB]
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the hypothesis that Charcot foot is associated with more vascular complications compared to matched diabetic patients without Charcot foot and to classify patients with Charcot foot according to the human genetic classification of the Qatari population.

Conditions

Charcot Arthropathy; Type 2 Diabetes

Outcome Measures

Primary Outcomes (4)

• Charcot Foot's vascular complications

  Assess the hypothesis that Charcot Foot is associated with more vascular complications compared to match diabetic patients without Charcot foot

  6 months

• Charcot foot in monocyte epigenetics

  Assess the hypothesis that Charcot foot disease reflects differences in monocyte epigenetics compared to other controls, particularly in genes involved in inflammation.

  6 months

• Assess the effect of initial methylation on kidney function in patients with type 2 diabetes mellitus, weather they have or not Charcot foot disease and for whom we have baseline kidney function, in a 2-year follow-up.

  6 months

• HBA1C >8.5% on total and gene-specific methylation.

  Assess the effect of improving diabetes control in patients with type 2 diabetes (Charcot foot and non-charcot foot patients) and a HBA1C \>8.5% on total and gene-specific methylation.

  6 months

Study Arms (3)

Group I: T2D and Charcot foot

Individuals with confirmed diagnosis of type 2 diabetes, using the American Diabetes Association guidelines and confirmed diagnosis of Charcot foot, based on clinical and radiological evidence of Charcot foot.

Group II: T2D neuropathy, no charcot

Individuals with type 2 diabetes and presence of neuropathy but the absence of Charcot foot.

Group III: Control, non-diabetic

Individuals without history of type 2 diabetes.

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited for the study at Hamad Medical Corporation. Most of the subjects will belong to the oupatient clinics.

You may qualify if:

• Must provide informed consent
• Must hold Qatari passport
• Males or Females ages 30 years or older to minimize the potential confounding contribution of other forms of diabetes mellitus
• In patients with Diabetes, no concomitant diseases except for micro- and macrovascular complications of diabetes (nephropathy, retinopathy, peripheral arterial disease, coronary artery disease, neuropathy) or symptoms of the metabolic syndrome (hypertension, dyslipidemia and obesity).
• Not taking any chronic medications (except of the diabetes, cardiovascular related drugs, anti-inflammatory drugs and/or any other treatment used for Charcot foot).

You may not qualify if:

• Other forms of diabetes (Type I, MODY, secondary diabetes)
• Active pregnancy
• Active infection or acute illness of any kind (except for Charcot foot)
• Chronic inflammation (auto-immune diseases) or infection
• Evidence of malignancy within the past 5 years
• Chronic hematological disorders known to affect HBA1C results such as hemoglobinopathies (e.g., sickle cell disease and thalassemia), increased red-cell turnover (e.g., hemolytic anemia and spherocytosis)
• Acute or critical limb ischemia.
• Osteomyelitis
• History of recent (within 6 months) immunosuppressive treatment including corticosteroids and anti-TNF-alpha compounds.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Hamad Medical Corporation: collaborator
• Weill Cornell Medical College in Qatar: collaborator

Study Sites (1)

Hamad Medical Corporation

Doha, Qatar

Location

Related Publications (1)

• Pasquier J, Ramachandran V, Abu-Qaoud MR, Thomas B, Benurwar MJ, Chidiac O, Hoarau-Vechot J, Robay A, Fakhro K, Menzies RA, Jayyousi A, Zirie M, Al Suwaidi J, Malik RA, Talal TK, Najafi-Shoushtari SH, Rafii A, Abi Khalil C. Differentially expressed circulating microRNAs in the development of acute diabetic Charcot foot. Epigenomics. 2018 Oct;10(10):1267-1278. doi: 10.2217/epi-2018-0052. Epub 2018 Jun 5.

  PMID: 29869523 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood Urine

MeSH Terms

Conditions

Arthropathy, Neurogenic; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• Charbel Abi Khalil, MD

  Weill Cornell Medical College in Qatar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: December 15, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: January 14, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share

Locations

QA (1)