NCT00667498已完成4 期
Metabolic Effect of Metformin in Obese Insulin Resistant Adolescents With Normal Glucose Tolerance
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Assessment of insulin sensitivity: Whole Body Insulin Sensitivity Index (WBISI), Homeostasis Model Assessment of Insulin Resistance (HOMA-IR), and Euglycemic hyperinsulinemic clamp
研究概览
简要总结
The primary objective of this randomized, parallel group, double-blind, placebo-controlled study is to determine whether treatment with metformin enhances insulin sensitivity in a group of ethnically diverse obese insulin-resistant adolescents with normal glucose tolerance.
详细描述
First Visit
Patients who agree to participate in this research study, will have an initial screening where the subject will be asked about his/her health, a sample of blood will be drawn, the subject will be examined, and an oral glucose tolerance (OGTT) test will be done.
- OGTT: The study takes about four hours and will begin on an "empty stomach." A small I.V. will be placed in a vein in the subject's arm. The I.V. will allow a member of the research team to take small amounts of blood for measuring glucose and other substances that circulate in the blood. About 7 tablespoons of blood will be drawn in total during the OGTT. The I.V. will remain in place all during the study. At the beginning of the study, the subject will be asked to drink about 8 ounces (one cup) of a high sugar cola- or orange-flavored drink.
If the subject meets all the requirements to be in the study and has a normal glucose tolerance test, he/she will be randomized to either the intensely (Euglycemic hyperinsulinemic clamp) or standard studied group and have the following six or seven tests performed: DEXA scan and Tanita, exercise step test, PAT test, MRI (Abdominal scan), MRS (leg scan), and Euglycemic hyperinsulinemic clamp (intensely studied group only). All of the tests are described below. Females will have a urine pregnancy test before each of these tests. If positive, the subject will not be allowed to participate/continue with the study.
- DEXA / Tanita: The DEXA scan will measure how much muscle and fat is in the subject's body and how dense the subject's bones are using an x-ray technique. Directly after the DEXA Scan, the subject's percentage of body fat will be measured using a Tanita scale.
- Exercise Step Test: The subject will be asked to step up and down two steps 20 times at their own pace. We will measure the subject's heart rate directly before and for three minutes after this exercise. After a ten minute break, the test will be repeated.
- Peripheral Arterial Tonometry (PAT): This test will allow us to evaluate the response of the small blood vessels in the subject's arm to changes in nerve signals to them. During this test, we will put a probe (similar to a tight-fitting glove) on one finger of each of the subject's hands and take some measurements for about five minutes. The probes contain latex, so this test will not be performed on subjects who are allergic to latex. Following these measurements, we will block blood flow to one of the hands for five minutes by putting a blood pressure cuff on one of the arms and inflating the cuff. After the pressure in the cuff is released, we will take more measurements for about five minutes.
- MRI (Belly Scan): Magnetic Resonance Imaging (MRI) will be used to take pictures of the subject's belly. These pictures will allow us to calculate how much fat the subject has just below the skin and how much fat is deeper inside the belly. We will also be able to estimate the percentage of fat in the subject's liver.
- MRS (Leg scan): We will measure how much fat is in the subject's calf muscle using magnetic resonance spectroscopy (MRS).
- Insulin, Glucose and Glycerol Infusion Study (Euglycemic hyperinsulinemic clamp): A small I.V. will be placed into a vein in each arm. One I.V. will be used to take out small amounts of blood for measuring the blood sugar and other substances that circulate in the blood. The other I.V. will be used to infuse insulin, glucose, and glycerol into the subject's blood. Insulin is a hormone that helps bring blood sugar into the cells. Glycerol is a component of fat that is normally present in a person's body.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Attending weight management clinic at Yale New Haven Hospital
- •Good general health, taking no other medication on a chronic basis
- •Age 13 to 17 yrs in puberty (girls: breast Tanner stage II to IV, and boys: testes size > 6 ml)
- •The presence of insulin resistance, defined by fasting insulin levels greater than 30 µU/ml, and HOMA insulin resistance index > 6
- •Normal glucose tolerance based on a 2-hr plasma glucose (<140 mg/dl) after the OGTT.
- •All female subjects must have a negative urine pregnancy test during the study visits and must use an effective method of contraception if they are sexually active. Without their parent(s) present, all potential female subjects will be asked about their sexual activity and the specific form of contraception they are using.
排除标准
- •Baseline creatinine > 1.0 mg/dl
- •Hepatic disease with elevated liver function test (ALT or AST) ≥ 2 X the upper limits of normal
- •Pregnancy
- •Presence of other endocrinopathies; except treated hypothyroidism on stable replacement doses of thyroid hormone
- •Presence of cardiac, pulmonary or other significant chronic illness
- •Adolescents with psychiatric disorder, claustrophobia or with substance abuse
- •Recent use (within six months) of anorexic agents
- •Presence of anemia (hematocrit < 35)
- •Mixed ethnic background (defined as two parents of different ethnicity)
- •Adolescents with metal implants (i.e. cardiac pace maker, metal prostheses, bullet remnants)
研究组 & 干预措施
1
Experimental
干预措施: Metformin (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Assessment of insulin sensitivity: Whole Body Insulin Sensitivity Index (WBISI), Homeostasis Model Assessment of Insulin Resistance (HOMA-IR), and Euglycemic hyperinsulinemic clamp
时间窗: Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).
次要结局
- Body mass index (BMI)(Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).)
- Waist to hip circumference ratio(Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).)
- Muscle lipid content(Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).)
- Total body fat(Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).)
- Abdominal fat mass(Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).)
- Hepatic fat fraction(Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).)
- Hepatic iron concentration(Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).)
- Plasma ghrelin levels(Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).)
- Adiponectin levels(Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).)
- Leptin levels(Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).)
- Blood pressure(Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).)
- Lipid profile(Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).)
- Microalbuminuria(Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).)
- Inflammatory markers (Plasminogen activator inhibitor-1 (PAI-1), C-reactive protein (CRP), homocysteine, tumor necrosis factor (TNF)-α, Interleukin (IL)-6)(Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).)
- Self-paced step test (Heart rate recovery after exercise)(Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).)
- Peripheral Arterial Tonometry (PAT)(Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).)
- Females only: Markers of polycystic ovarian syndrome (PCOS) - Adrenal androgens (17 Hydroxyprogesterone, Dehydroepiandrosterone), sex hormone binding globulin (SHBG), free testosterone, LH/FSH ratio(Baseline (month 0), post 3-month intervention (month 4), and post 6-month extension (month 10).)
- Females only: Menstrual pattern(Throughout study)
- Ethnic stratification (Hispanic, African American or Caucasian)(Baseline (month 0))
研究者
研究点 (1)
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