The Effect of Lactation on Insulin Sensitivity and Lipolysis in Women
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Whole Body Lipid Turnover Rates
研究概览
简要总结
This purpose of this study is to investigate whether lactation improves insulin sensitivity and increases lipolysis in women.
详细描述
There are two aims that this research will address.
In Aim 1, the research question is "Does lactation improve insulin sensitivity and increase lipolysis in women?" In this Aim, researchers will assess whether lactation amongst women with a history of gestational diabetes mellitus (GDM) will improve whole body insulin sensitivity as well as increase whole body lipid turnover by using hyperinsulinemic-euglycemic clamps combined with [6,6-2H]-glucose and [2H5]-glycerol infusions. These stable, non-radiating isotopes have been used extensively and safely to study the mechanisms of insulin resistance amongst non-pregnant as well as pregnant humans; however, these techniques have not previously been applied to the study of insulin sensitivity during lactation. Therefore, the goals will be two-fold: 1) to determine whether lactation induces similar changes in insulin sensitivity in humans as in mice and 2) to pilot the feasibility of performing larger, more detailed metabolic studies in this population of women post-partum.
The second aim (Aim 2) will use a retrospective chart review of women with a history of GDM who had an oral glucose tolerance test (OGTT) 6-8 weeks post-partum as part of standard of care.
The focus of this protocol registration will be Aim 1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- 否
入选标准
- •A history of GDM (as defined as the American Diabetes Association criteria)
- •Delivered a singleton, live birth at ≥ 35 weeks gestation within the past 18 months
- •HbA1C < 6.5% at time of screening
- •Delivery within the past 18 months
- •Breast Feed Group: exclusively or mostly breast-fed (< 6 ounces of formula/24 hours at 6-9 weeks of delivery) for at least 4-6 months
排除标准
- •Currently lactating or lactation within the past 1 month at the time of the screening visit
- •Diagnosis of diabetes (T1D or T2D) prior to pregnancy
- •Current use of any glucose-lowering agents
- •Pregnancy related medical problems including preeclampsia
- •Major congenital fetal anomalies
- •Creatinine > 1.5mg/dL, Hematocrit < 35%, ALT and AST > 2.5X upper limit of normal
- •Known psychiatric disorders, alcohol abuse, HIV, hepatitis, renal disease, hepatic disease, untreated heart disease, untreated thyroid disease, active systemic infection or malignancy
- •Illicit drug use (by the participant's self-report)
- •History of post-partum depression
- •Use of weight loss supplements or dieting 6 months prior to study
- •Corticosteroid or opiate use within 6 months of study
结局指标
主要结局
Whole Body Lipid Turnover Rates
时间窗: 4 hours
Determined with \[2H5\] Glycerol tracer given during the hyperinsulinemic-euglycemic clamp study. Tracer levels in the plasma determinates how the body uses fat in the blood during the hyperinsulinemic-euglycemic clamp study.
Whole Body Insulin Sensitivity Measured by the Glucose Infusion Rate
时间窗: 2 hours and 4 hours
The glucose infusion rate is determined by the amount of 20% dextrose given during the hyperinsulinemic-euglycemic clamp study, necessary to keep blood glucose levels at the target range (90-100 mg/dL). Higher rates of infused dextrose indicates greater sensitivity to infused insulin during the hyperinsulinemic-euglycemic clamp. Women with gestational diabetes are expected to be insulin resistant.
Endogenous Glucose Production
时间窗: 4 hours
Determined with \[6,6-2H\] Glucose tracer given during the hyperinsulinemic-euglycemic clamp study. Lower values of endogenous glucose production indicates greater hepatic insulin sensitivity.
次要结局
- Triglycerides(4 hours)
- Plasma NEFA(4 hours)
- Insulin Levels(4 hours)