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The ameliorating effect of gut microbiota-targeted nutritional intervention on metabolic dysfunction in PCOS patients

The ameliorating effect of gut microbiota-targeted nutritional intervention on metabolic dysfunction in PCOS patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-14005075
Enrollment
Unknown
Registered
2014-07-17
Start date
2014-08-12
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

polycystic ovary syndrome

Interventions

WTP:Whole grains, traditional Chinese medicinal foods and prebiotics diet
APW:acarbose+Whole grains, traditional Chinese medicinal foods and prebiotics diet

Sponsors

Shanghai First People's Hospital, Shanghai Jiao Tong University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
15 Years to 70 Years

Inclusion criteria

Inclusion criteria: The following inclusion criteria were established for patients with PCOS: chronic anovulation (cycles more than 35 days or amenorrhea-lack of menstruation for more than 6 months), signs of hyperandrogenism (hirsutism, acne seborrhea, and obesity), elevated LH/FSH ratios, and elevated serum T levels. By transvaginal ultrasound, all patients with PCOS showed subcapsular, peripherally located less than 8 mm follicles and hyperechogenic stroma. All patients were in good health,and none had taken any medication affecting carbohydrate metabolism or gonadal functions in the last 6 months. Thyroid function tests, serum PRL levels, and pubertal and sexual development were recorded as normal; BMI more than 18 kg/m2; 15-70 years old; Participate no other research project; Providing written informed consent and others; Having good compliance: no business trips, no outdoor dining, regular work and rest time, having a buring desire to change his physical condition.

Exclusion criteria

Exclusion criteria: Alterations of renal function (creatinine, 1.3mg/dl and urea, 40mg/dl), alterations of thyroid function (thyroid-stimulating hormone (TSH), 5.50mIU/ml and free thyroxin, 1.76 ng/dl), presence of hyperprolactinaemia (20 ng/ml), presence of congenital adrenal hyperplasia (dehydroepiandrosterone sulphate (DHEA-S), 350mg/dl and 17-hydroxyprogesterone (17-OHP), 180 ng/ml), presence of diabetes (fasting glycaemia of 126mg/dl), and the use of hormonal medications or medications that might interfere with carbohydrate metabolism over the last 6 months;People who used any drug or surgery for the purpose of weight control; Alcoholic; People that received medical treatments in the last 3 months for following diseases: gallstones, gastro-intestinal ulcer, urinary infection, acute pyelonephritis, cystitis; People received surgery on GI tract except for appendicectomy or that for hernia; People with severe hepatic diseases, such as chronic or persisting hepatitis and sclerosis, and people with hepatic dysfunction (ALT or AST more than 2.5 times of upper normal limit); People with acute or chronic renal dysfunction, and uremia; People with organic diseases, such as tumor/cancer, coronary heart disease, miocardial infarction, stroke; People with infectious disease such as pulmonary tuberculosis or AIDS; People with epilepsy; People with congenital heart disease; People with systemic lupus erythematosus; People with aplastic anemia, or Idiopathic thrombocytopenic purpura, or anemia (Hb less than 10g/dl); People used antibiotics for more than 3 days in last 3 months; Pregnant women; People with severe psychological disease during last 6 months.

Design outcomes

Primary

MeasureTime frame
OGTT Insulin;

Secondary

MeasureTime frame
HOMA-IR;HbA1c;OGTT Glucose;HOMA-beta Index;Cholesterol;Triglyceride;Low Density Lipoprotein;High Density Lipoprotein;Weight;Body Mass Index;Waistline;Hipline;Body Fat Distribution;Blood Pressure;CEA;CA125;Intestines secrete peptide;The compositioin of gut microbiota;The metabolism of gut microbiota;Gut microbiota function;Blood chemistry for liver function;Blood chemistry for kidney function;blood routine;Urine Routine;Electro Cardio Gram;Fatty liver outcome measurements assessed by MRI;polycystic ovary assessed by ultrasounds;Body Fat Distribution assessed by DEXA;Drug Usage;sex hormone;

Contacts

Public ContactYongde Peng Liping Zhao
pengyongde0908@126.com+86 13386259649 or 13817866559

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 13, 2026