Effect of T6 Dermatome Electrical Stimulation on Gastric Motor Functions, Appetite, Satiation, Satiety and Weight Loss in Individuals With Overweight and Class I Obesity
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Gastric Half-emptying Time (GE T 1/2)
研究概览
简要总结
Investigators are doing this research study to find out the effect of T6 dermatomal electrical stimulation (delivered by a Transcutaneous Electrical Nerve Stimulation (TENS) unit) on appetite and weight loss.
详细描述
Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a Transcutaneous Electrical Nerve Stimulation (TENS) unit. Participants will receive 15-minute T6 dermatome cutaneous stimulation with TENS unit applied immediately before ingestion of two of main meals of the day (breakfast and evening meal), and 60 minute stimulation applied immediately after ingestion of these meals. Participants will apply the stimulus four times daily for a treatment period of at least 3 months. Participants will keep a diary of weight once weekly and a weekly appetite record.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Overweight and obese adults (BMI ≥25 kg/m2 and ≤34.99 kg/m2) residing within 125 miles of Mayo Clinic in Rochester, Minnesota; these will be otherwise healthy individuals with no unstable psychiatric disease and not currently on treatment for cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, or endocrine (other than hyperglycemia on diet) disorders.
- •Age: 18-65 years
- •Gender: Men or women. Women of childbearing potential will be using an effective form of contraception, and have negative pregnancy tests within 48 hours of enrollment and before each radiation exposure.
- •Subjects must have the ability to provide informed consent before any trial-related activities.
- •Eligible individuals will be asked to avoid taking additional medications and supplements for the duration of the study, unless reviewed and approved by the study team.
排除标准
- •Abdominal surgery other than appendectomy, Caesarian section or tubal ligation
- •Positive history of chronic gastrointestinal diseases, systemic disease that could affect gastrointestinal motility, or use of medications that may alter gastrointestinal motility, appetite or absorption, e.g., Orlistat
- •Positive history of diabetes mellitus or use of hypoglycemic medications
- •Positive history of spinal cord injury and/or chronic back pain
- •Significant untreated psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Inventory (HAD) (12), a self-administered alcoholism screening test (AUDIT-C) (13), and the Questionnaire on Eating and Weight Patterns (binge eating disorders and bulimia) (14). If such a dysfunction is identified by a HAD score >11 or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up.
- •Intake of medication, whether prescribed or over the counter (except multivitamins), within 7 days of the study. Exceptions are birth control pill, estrogen replacement therapy, thyroxine replacement therapy, low dose analgesia or anti-inflammatory medications (Acetaminophen and Ibuprofen) and any medication administered for co-morbidities as long as they do not alter gastrointestinal motility including gastric emptying and gastric accommodation.
- •Subjects may also be excluded from participation for other factors at the discretion of the principal investigator.
研究组 & 干预措施
Transcutaneous electrical nerve stimulation (TENS)
Healthy volunteers who are overweight or have class I obesity will receive T6 dermatomal electrical stimulation via Transcutaneous electrical nerve stimulation (TENS)
干预措施: Transcutaneous electrical nerve stimulation (TENS) (Device)
结局指标
主要结局
Gastric Half-emptying Time (GE T 1/2)
时间窗: At 3 months, approximately 2 hours after radiolabeled meal is ingested
The time for half of the ingested solids to leave the stomach
Change in Body Weight
时间窗: Baseline, 3 months
Change in body weight will be measured in kilograms or pounds
Gastric Half-emptying Time (GE T 1/2)
时间窗: After 1 day treatment (approximately at 4 hours)
The time for half of the ingested solids to leave the stomach
次要结局
- Fasting Gastric Volume by 99mTc-SPECT Imaging(At 3 months, approx 20 minutes after 99mTC injection)
- Satiation Volume (Level 3)(Approximately 30 minutes after the liquid meal)
- Change in Fasting and Peak Postprandial Plasma Ghrelin at 3 Months(baseline, 90 minutes postprandially)
- Change in Fasting and Peak Postprandial Glucagon-like Peptide-1 (GLP-1) at 3 Months(baseline, 90 minutes postprandially)
- Change in Fasting and Peak Postprandial Peptide Tyrosine Tyrosine (PYY) at 3 Months(baseline, 90 minutes postprandially)
- Postprandial Gastric Volume (Gastric Accommodation) by 99mTc-SPECT Imaging(At 3 months, approximately 30 min after liquid meal)
- Change in Gastric Emptying Percentage(Day 1, 3 months)
- Mean Kcal Intake at Buffet Meal as a Measure of Appetite(At 3 months, approximately 30 minutes after the buffet meal)
- Satiation Maximum Tolerated Volume (Level 5)(Approximately 30 minutes after the liquid meal)
- Change in Appetite Score(Baseline, 3 months)
研究者
Michael Camilleri, MD
Principal Investigator
Mayo Clinic