Clinical Trial: Microcirculation and Bone Metabolism in Patients With Type 2 Diabetes Mellitus and Charcot Foot - A Pilot Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Bone Metabolism and Endothelial Function in Patients With Type 2 Diabetes Mellitus and Charcot Foot - an Observational Comparative Study

Brief Summary:

This study is part of a research project for a University MD Program. This is an observational study aimed at comparing the differences in bone metabolism and microcirculation in patients with type 2 diabetes mellitus (with and without diabetic neuropathy and Charcot foot) with healthy subjects.

Diabetes is gradually becoming a global epidemic along with its associated complications. Diabetes can affect several systems in our body particularly the eyes, nerves and the kidneys. The damaging effects occur at the level of the small blood vessels (microcirculation) that supply these vital structures. Normally, the inner lining of these blood vessels (endothelium) plays a very important role in maintaining adequate blood flow. The endothelium releases a chemical substance called nitric oxide, which relaxes these small blood vessels thereby ensuring sufficient blood supply to these key structures. Nitric oxide also prevents blockage of these vessels. Any form of metabolic stress like hyperglycaemia (raised blood sugar as seen in diabetes) can cause abnormal changes in the normal behaviour of the endothelium (endothelial dysfunction). Therefore hyperglycaemia promotes endothelial dysfunction by lowering nitric oxide levels, which may lead to diabetic complications like diabetic retinopathy (eye damage), nephropathy (kidney damage) or neuropathy (nerve damage).

In addition, patients with diabetes also suffer from osteoporosis (thinning of bones). Osteoporosis is a bone disorder characterised by a reduction in bone mineral content leading to an increased risk of developing fractures. The increased risk of fractures in patients with type 2 diabetes is attributed to poor bone quality resulting from the harmful effects of high blood glucose. Studies have also shown that nitric oxide has a bone protective effect as demonstrated by its

Detailed Summary:

This is an observational study aimed at observing and comparing differences in bone metabolism and microcirculation in patients with type 2 diabetes and healthy controls.

In this study, 50 participants will be recruited and then categorised into the following groups:

  1. Control group: 10 healthy volunteers (Hospital staff and spouses/ partners of patients will volunteer as healthy subjects)
  2. Type 2 diabetic patients without neuropathy: 10

  3. Type 2 diabetic patients with neuropathy:

    • 10 patients with painless neuropathy
    • 10 patients with painful neuropathy
  4. Type 2 diabetic patients with unilateral Charcot foot: 10

Visit Schedule The estimated time for enrollment of patients will be within 3 months. The duration of the study is 5 months.

Screening (-2 Weeks): To assess for eligibility. This will include informed consent process, medical history and physical examination, screening for neuropathy and routine bloods. Laboratory work-up done at screening will be considered for data analysis.

Visit 1 - Baseline visit

  • Anthropometric measures: Height, weight, BMI, waist circumference
  • Vital parameters: supine and standing blood pressure, pulse, respiratory rate and temperature

  • Laborato
    Sponsor: Tameside General Hospital

    Current Primary Outcome:

    • Impaired endothelial function in patients with type 2 DM with/ without diabetic neuropathy and Charcot foot compared to their healthy counterparts as measured by: [ Time Frame: At baseline ]
      Endothelial-dependent and independent vasodilatations
    • Impaired endothelial function in patients with type 2 DM with/ without diabetic neuropathy and Charcot foot compared to their healthy counterparts as measured by: [ Time Frame: at baseline ]
      Markers of endothelial activation, which include adhesion molecules like ICAM, VCAM and inflammatory molecules.
    • Impaired endothelial function in patients with type 2 DM with/ without diabetic neuropathy and Charcot foot compared to their healthy counterparts as measured by: [ Time Frame: at baseline ]
      Serum Nitric oxide
    • Impaired endothelial function in patients with type 2 DM with/ without diabetic neuropathy and Charcot foot compared to their healthy counterparts as measured by: [ Time Frame: at baseline ]
      Advanced glycation end-products


    Original Primary Outcome: Impaired endothelial function in patients with type 2 DM with/ without diabetic neuropathy and Charcot foot compared to their healthy counterparts. [ Time Frame: at baseline ]

    Impaired endothelial function in patients with type 2 DM with/ without diabetic neuropathy and Charcot foot compared to their healthy counterparts as measured by:

    • Endothelial-dependent and independent vasodilatations
    • Markers of endothelial activation, which include adhesion molecules like ICAM, VCAM and inflammatory molecules.
    • Serum Nitric oxide
    • Advanced glycation end-products


    Current Secondary Outcome:

    • Impaired bone metabolism in patients with type 2 DM with/ without diabetic neuropathy and Charcot foot compared to their healthy counterparts as assessed by: [ Time Frame: At baseline ]
      Bone turnover markers like P1NP, CTX, Sclerostin, RANKL, OPG, OPN, OCN, BMP4 and TGF-1β.
    • Impaired bone metabolism in patients with type 2 DM with/ without diabetic neuropathy and Charcot foot compared to their healthy counterparts as assessed by: [ Time Frame: At baseline ]
      Calcaneal bone mineral density (BMD)


    Original Secondary Outcome: Impaired bone metabolism in patients with type 2 DM with/ without diabetic neuropathy and Charcot foot compared to their healthy counterparts. [ Time Frame: At baseline ]

    Impaired bone metabolism in patients with type 2 DM with/ without diabetic neuropathy and Charcot foot compared to their healthy counterparts.

    • Bone turnover markers like P1NP, CTX, Sclerostin, RANKL, OPG, OPN, OCN, BMP4 and TGF-1β.
    • Calcaneal bone mineral density (BMD)


    Information By: Tameside General Hospital

    Dates:
    Date Received: April 27, 2015
    Date Started: June 2015
    Date Completion: March 2016
    Last Updated: March 14, 2016
    Last Verified: March 2016