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临床试验/NCT03916263
NCT03916263已完成早期 1 期

Compare Weight Loss and Metabolic Improvements Using a Low Starch Dietary Education Program vs. Traditional Treatment for Polycystic Ovary Syndrome (PCOS)

Texas Tech University Health Sciences Center1 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2018年8月29日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
71
试验地点
1
主要终点
Weight

研究概览

简要总结

Compare weight loss and metabolic parameters in patients using a low starch dietary education program vs. traditional treatment (i.e., prescribing metformin, low calorie diet and exercise) for health improvement in women with PCOS.

详细描述

Polycystic ovary syndrome (PCOS) is a common gynecologic condition diagnosed by the presence of irregular menstruation, high androgen levels and polycystic appearing ovaries by ultrasound. PCOS affects approximately 5 million women of reproductive age in the United States and is associated with increased risk of obesity, diabetes, cardiovascular disease, cancer and infertility. Women with PCOS are at 5- to 10-fold risk of developing type 2 diabetes and are diagnosed on average 30 years sooner than women without PCOS. Historically, high insulin levels worsen symptoms of PCOS and make weight loss very difficult despite the patient's best efforts. Research shows that carbohydrates from dairy and starch-based foods have greater insulin-producing properties than carbohydrates from non-starchy vegetables and fruits. The purpose of this study is to compare metabolic parameters in patients using a low starch dietary education program vs. traditional treatment (i.e., prescribing metformin, low calorie diet and exercise) for health improvement in women with PCOS.

In the investigator's previous work, study participants received approximately 1.5 hours of one-on-one dietary instruction by a Registered Dietitian. Dietary instruction included review of a list of foods that participants could eat with no restrictions as well as a list of foods to avoid, i.e. grains and dairy products. Study participants, all of whom were overweight or obese, achieved an average weight loss of 18.9 pounds in 8 weeks. In addition, study participants demonstrated improvements in triglycerides, total and free testosterone and in clinical hair growth scores. This study will investigate whether the same positive results might be achieved using a web-based written and video program for dietary guidance. If successful, the dietary video instructions may potentially benefit a large number of women by providing health care providers with a practical and affordable method to provide dietary instructions to their patients with PCOS, especially in areas where access to a Registered Dietitian is limited.

The goal of this prospective, randomized, controlled, clinical trial is to develop a practical, clinically useful web-based tool for health care providers to educate their patients on an optimal eating plan to manage PCOS.

AIM:

1.Compare weight loss and metabolic parameters in patients using a low starch dietary education program vs. traditional treatment (i.e., prescribing metformin, low calorie diet and exercise) for health improvement in women with PCOS.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women ages 18-45
  • BMI of >25 but < 45
  • Access to a computer/phone/electronic device with internet connection.

排除标准

  • Pregnancy
  • Abnormal thyroid stimulating hormone (TSH)
  • Hyperprolactinemia
  • adrenal hyperplasia
  • Cushing's disease Ovarian and adrenal tumors. Previous diagnosis of diabetes. History of eating disorder History of surgical weight loss procedure Persons with an inability to give informed consent Persons unable/unwilling to exercise or to prepare their own food

研究组 & 干预措施

Traditional Treatment

Experimental

Participant receives recommendations for caloric intake, exercise and prescription for metformin if indicated

干预措施: Metformin (Drug)

One-On-One Low Starch Dietary Instruction

Other

Participant receives One-On-One Low Starch Dietary Instruction from Study Collaborator

干预措施: One-On-One Dietary Instruction (Other)

Low Starch Dietary Instruction by Video

Other

Participant receives Low Starch Dietary Instruction by Video Link

干预措施: Video Dietary Instruction (Other)

结局指标

主要结局

Weight

时间窗: 8 weeks

Weight

BMI

时间窗: 8 weeks

BMI

次要结局

  • fasting glucose(8 weeks)
  • fasting insulin(8 weeks)
  • cholesterol(8 weeks)
  • testosterone(8 weeks)
  • hemoglobin A1c(8 weeks)
  • waist to hip ratio(8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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