Vascular and Metabolic Changes in Postmenopausal Diabetics

NCT03273738 | Unknown

• 1 other identifier: Postmenopausal DM
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The presence of type 2 diabetes mellitus (T2DM) also increases the relative risk of developing cardiovascular disease in women compared to men. Carotid intima media thickness (IMTc) was increased with reduction in brachial artery flow-mediated dilation (FMD) in T2 DM patients and inversely and strongly related to the extent of hyperglycemia. Low concentrations of folate and vitamin B12 involved in homocysteine metabolism are also associated with increased risk of vascular damage. the aim is to relate, if found, the degree of metabolic changes to the extent in vascular parameters changes in type 2 diabetic postmenopausal women.

Conditions

Diabete Type 2

Keywords

type 2 diabetes; postmenopausal

Outcome Measures

Primary Outcomes (2)

• metabolic changes in type 2 diabetes

  changes in folate level in type 2 diabetes mellitus

  baseline and 3 months

• metabolic changes in type 2 diabetes

  B12 level and their relation to complications

  baseline and 3 months

Study Arms (2)

postmenopausal diabetic women

50 female patients with T2DM who visited Assiut University Hospital Diabetes Clinic in Assiut, Egypt in these patients folate level measurement, B12 level and homocysteine are measured

Diagnostic Test: folate level measurement; Diagnostic Test: B12

postmenopausal without diabetes

Another 50 participants will be volunteered in the study as control.n these subjects folate level measurement', B12 level and homocysteine are measured

Diagnostic Test: folate level measurement; Diagnostic Test: B12

Interventions

folate level measurement DIAGNOSTIC_TEST

the level of folate measured in plasma with homocysteine

postmenopausal diabetic women; postmenopausal without diabetes

B12 DIAGNOSTIC_TEST

B12 measurement in blood

postmenopausal diabetic women; postmenopausal without diabetes

Eligibility Criteria

• Age: 50 Years - 70 Years
• Gender Eligibility Details: postmenopausal women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

post-menopausal women aged 50-70 years with amenorrhea for over 24 months will be recruited. The diabetic participants will receive their treatment for T2DM (oral hypoglycemic agents or insulin).

You may qualify if:

• post-menopausal women
• aged 50-70 years
• amenorrhea for over 24 months.
• The diabetic participants will receive their treatment for T2DM (oral hypoglycemic agents or insulin).

You may not qualify if:

• Patients receiving hormone replacement therapy.
• History of abnormal vaginal bleeding.
• Patients receiving vitamin B12, vitamin D and folic acid regularly.
• History of malignancy or neurological diseases as epilepsy, parkinsonism and Alzheimer disease.
• Antifolate medications as methotrexate are excluded from the study.

Sponsors & Collaborators

• Assiut University: lead

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

• Lobna F Eltoony

  internal medicine

  STUDY CHAIR

Central Study Contacts

Ahmed M Abd-Eldayem, MD

CONTACT

01005885676; ah_nmre@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: August 30, 2017
• First Posted: September 6, 2017
• Study Start: October 2, 2018
• Primary Completion: October 10, 2018
• Study Completion: November 15, 2018
• Last Updated: June 27, 2018

Record last verified: 2018-06