Is Weight Change and Glucoregulation Related to Dietary Intake, the Gut Microbiome or the Interaction Between The Two Variables?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Intestinal Microbiome Composition
研究概览
简要总结
The purpose of this study is to investigate a persons dietary intake and its effect on the gut microbiome and the association of those two variables on weight and glucoregulation. Specifically, the investigators will compare the gut microbiota, fasting glucose and insulin, c-peptide and hemoglobin A1-c in three groups of subjects: obese patients (BMI ≥ 30 kg/m2) with type 2 diabetes mellitus (T2DM), obese patients without T2DM, and normal weight lean controls without T2DM. Each patient will also complete a detailed dietary recall (ASA-24) to investigate the association with diet, microbiome and weight/glucoregulation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18-65 (inclusive, at time of informed consent)
- •BMI ≥ 30 kg/m2 with T2DM
- •BMI ≥ 30 kg/m2 without T2DM
- •Normal weight lean controls without T2DM
排除标准
- •Tobacco use in past three months - will add unnecessary confound to the data.
- •Taking a medication on a routine/recent basis which is known to significantly influence gastrointestinal transit time or affect the microbiome or other variables significantly (as determined by study pharmacist/MD)
- •Has taken an oral or injectable antibiotic in the past 3 months
- •Has taken a commercially prepared probiotic and/or prebiotic agent in the 3 months
- •History of significant intestinal disease or disorder (e.g., crohn's disease, ulcerative colitis)
- •History of gastrointestinal surgery that may impact measures of biological variables, as determined by the investigator
- •Medical condition expected to impact the biological variables of interest or interfere with providing a sample, as determined by the investigator.
- •Unable to speak/read English
- •Breastfeeding, pregnant, or planning to become pregnant within the duration of the study as assessed through self-report on medical history
- •Unwilling to use a medically acceptable form of contraception during study involvement. Medically acceptable forms of contraception include oral contraception, physical barrier methods and/or abstinence.
- •Any known infectious disease such as Viral Hepatitis or HIV (as determined by study pharmacist/MD)
结局指标
主要结局
Intestinal Microbiome Composition
时间窗: One sample collected upon study enrollment
The ratio of firmicutes to bacteroidetes will be the primary focus of the microbiome evaluation.
次要结局
- Fasting Glucose(One sample collected upon study enrollment)
- Fasting Insulin(One sample collected upon study enrollment)
- C-peptide(One sample collected upon study enrollment)
- Hemoglobin A1-c(One sample collected upon study enrollment)
研究者
Kristine Steffen
Associate Professor, Pharm. D., Ph.D.
North Dakota State University