Impaired Glucose Tolerance in Vietnamese Infertile PCOS Women
Study Details
Study Description
Brief Summary
Polycystic ovary syndrome (PCOS) is a common endocrine and reproductive disorder in which insulin resistance (IR) is proposed as a key pathophysiological feature of the disease's symptoms and consequences. Impaired glucose tolerance (IGT) which is a significant consequence of IR, is related to a higher risk of diabetes mellitus, future cardiovascular events, and adverse pregnancy outcomes.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
All Vietnamese, infertile women, with PCOS according to the Rotterdam criteria present at IVFMD Tan Binh and IVFMD Phu Nhuan will be enrolled to the study. Phenotypes of PCOS are classified into A, B, C and D due to hyperandrogegism (HA), ovulatory dysfunction (OD) and polycystic ovarian morphology (PCOM)
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A: HA + OD + PCOM
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B: HA + OD
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C: HA + PCOM
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D: OD + PCOM
All patients enrolled in this study will have:
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Standard anthropometric data will be done by professional and experience physicians according to standard study protocol: Weight, height, waist and hip circumference, waist to hip ratio, BMI calculated, followed by World Health Organization guidelines for Asian women.
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Blood pressure
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Fat mass measure by specific caliper which are available at the clinic. Fat mass index (FMI) are classified as: deficit < 5, normal 5-9, excess female >9-13, obese >13
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Gynecologic ultrasound scan
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Blood tests:
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Hormonal profile evaluation: Luteinizing hormone (LH) (Roche Cobas e411, S: 25.816 mIU/mL, CV: 5.8%), Follicle-stimulating hormone (FSH) (Roche Cobas e411, S: 25.045 mIU/mL, CV: 5.8%), Estradiol (Roche Cobas e411, S: 210.390 ng/L, CV: 6.6%), Total testosterone, SHBG, androstenedione, TSH (Beckman Access - S: 2,712 ng/dL, CV: 5.6%), Total triiodothyronine (total T3) (Beckman Access - S: 7.284 pg/mL, CV: 6.1%), Free thyroxine (free T4) (Beckman Access - S: 2.712 ng/dL, CV: 5.6%), Prolactin (Roche Cobas e411 - S: 37.993 mcg/L, CV: 5.5%), Progesterone (Roche Cobas e411, S:10.553 ng/mL and CV: 5.4%),17(OH)-progesterone (Elisa, DRG International, S: 0.03 ng/ml and CV: 5.8-9.2%), Free androgen index (FAI) = Serum testosterone (nmol/L)/serum SHBG (nmol/L) × 100, HDL, LDL, Fasting serum insulin (Roche Cobas e411 - S: 1.39 pmol/L, CV: 1.4%), Insulin sensitivity is estimated by homeostasis model assessment of insulin resistance (1/HOMA-IR) index. HOMA-IR is calculated by the following formula: HOMA-IR = fasting plasma glucose (mmol/L) × fasting insulin (uIU/mL)/22.5
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Glucose tests:
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Fasting plasma glucose: will be measured by Humastar 600 System (Humastar
Systems,), sensitivity (S): 6.421 mmol/L and coefficient of variation (CV):
2.5% and performed when patients have already had fasting for at least 8 hours. A volume of 2 ml of blood will be withdrawn and contained in a vacutainer with additive of natri oxalate and EDTA. Diagnosis of diabetes mellitus will be made when fasting glucose ≥126 mg/dL (7 nmol/L) or HbA1C ≥6.5% (48 mmol/mol) (American Diabetes Association, 2018). When glucose ≥126 mg/dL (7 nmol/L) or HbA1C ≥6.5% (48 mmol/mol) (American Diabetes Association, 2018).
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Oral glucose tolerance test with 75 g glucose (75 g OGTT) will be performed to those with normal fasting glucose and HbA1C levels. Women will be recommended to have normal diet for 3 days and overnight fasting for at least 8 hours. The blood withdrawal will be performed twice: (i) fasting and (2i) 2 hours after solution administration. The volume of blood for each test is 2 ml. Impaired glucose tolerance will be diagnosed when two-hour glucose levels of 140 to 199 mg/dL (7.8 to 11.0 mmol/l) (American Diabetes Association, 2018).
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Hyperandrogenism:
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Clinical hyperandrogenism: Hirsutism using the modified Ferriman Gallwey score (mFG) and severe acnes
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Biochemical hyperandrogenism: free testosterone (normal range below 2,53nmol/ml), free testosterone index, SHBG
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Infertile PCOS women All Vietnamese, infertile women, diagnosed with PCOS according to the Rotterdam criteria (2003) at IVFMD Tan Binh and IVFMD Phu Nhuan will be enrolled to the study. |
Diagnostic Test: Oral glucose tolerance test
Oral glucose tolerance test with 75 g glucose (75 g OGTT) will be performed to those with normal fasting glucose and HbA1C levels. Women will be recommended to have normal diet for 3 days and overnight fasting for at least 8 hours. The blood withdrawal will be performed twice: (i) fasting and (2i) 2 hours after solution administration. The volume of blood for each test is 2 ml. Impaired glucose tolerance will be diagnosed when two-hour glucose levels of 140 to 199 mg/dL (7.8 to 11.0 mmol/l) (American Diabetes Association, 2018).
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Outcome Measures
Primary Outcome Measures
- Prevalence of patients with impaired OGTT [Baseline]
Impaired glucose tolerance will be diagnosed when two-hour glucose levels of 140 to 199 mg/dL (7.8 to 11.0 mmol/l) (American Diabetes Association, 2018)
Secondary Outcome Measures
- Prevalence of patients with diabetes mellitus [Baseline]
Diagnosis of diabetes mellitus will be made when fasting glucose ≥126 mg/dL (7 nmol/L) or HbA1C ≥6.5% (48 mmol/mol) (American Diabetes Association, 2018)
Eligibility Criteria
Criteria
Inclusion Criteria:
- Vietnamese women with polycystic ovarian syndrome diagnosed followed by Rotterdam criteria (2003) having indications for infertility treatments
Exclusion Criteria:
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Endocrinal abnormalities including thyroid-stimulating hormone (TSH) >5mIU/mL, serum prolactin (PRL) >30ng/mL and any other concomitant endocrinopathy such as a history of hypothyroidism, Cushing's syndrome, premature ovarian insufficiency and late-onset or non-classic congenital adrenal hyperplasia will be excluded.
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Women who were already diagnosed as diabetes by endocrinologists
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | My Duc Hospital | Ho Chi Minh City | Vietnam |
Sponsors and Collaborators
- Mỹ Đức Hospital
Investigators
- Principal Investigator: Lan TN Vuong, MS, PhD, Mỹ Đức Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CS/BVMĐ/20/07