The Effect of Pendulum Glucose Control on GI Symptoms and Glycemic Control in Subjects With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Decreased Gastrointestinal Symptoms
研究概览
简要总结
The study is a single site, prospective, open label, observational, single arm trial in 30 patients with type 2 diabetes with GI complaints using 1 or more oral or injectable anti-hyperglycemic agents to investigate if altering the microbiome though Pendulum T2D dietary supplementation can further enhance the efficacy of the current treatment while reducing the GI associated symptoms in patients with Type 2 diabetes.
详细描述
A high prevalence of gastrointestinal (GI) symptoms exist in both type 1 and type 2 diabetes that affect the quality of life negatively and substantially, although the underlying pathophysiology and relationship with glycemic control remain unclear. The current study aims to investigate if altering the microbiome though Pendulum T2D dietary supplementation can further enhance the efficacy of the current treatment while reducing the GI associated symptoms in patients with Type 2 diabetes mellitus who are already on a stable dose of metformin alone and/or alongside other oral or injectable anti-hyperglycemic agents (sulfonylurea agents, DPPIV inhibitor,Glucagon-like peptide (GLP)-1 agonist, sodium-glucose cotransporter (SGLT)-2 inhibitor and/or insulin) and with present GI symptoms. The study is a single site, prospective, open label, observational, single arm trial in 30 patients with type 2 diabetes with GI complaints using 1 or more oral or injectable anti-hyperglycemic agent and an HbA1C between 6.5% and 9.5%. The study will be 8 weeks in duration (2 weeks baseline and 6 weeks product intervention), with an option to continue to 6 months for those willing to continue taking the dietary supplement. As the study is observational and the data are to be used to for the purpose of evaluating improvement in GI symptoms during the intervention with Pendulum T2D there is no specific method to determine sample size.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index ≤ 45 kg/m
- •Subjects with type 2 diabetes that are on a stable dose of one or more injectable or oral antihyperglycemia agents for at least 8 weeks prior to screening.
- •HbA1c ≥ 6.5 % and ≤ 9.5% obtained at the screening visit.
- •Subjects with any gastrointestinal symptoms including but not limited to heartburn, indigestion, diarrhea, constipation.
- •Must be willing and be able to give written informed consent.
排除标准
- •Type 1 diabetes
- •Pregnant, nursing or planning pregnancy
- •Planning elective surgery in the next 8 weeks
- •Current or planned use of steroids, orally or injected
- •Diagnosis of irritable bowel disease , diverticulitis, other significant GI illness
- •Co-existing severe health condition, such as active cancer or unstable cardiovascular disease/congestive heart failure.
- •Severe allergy to tape or any component of the CGM device
结局指标
主要结局
Decreased Gastrointestinal Symptoms
时间窗: 6 weeks
Mean change from baseline in overall Gastrointestinal Symptom Rating Scale (GSRS) scores. The GSRS is a 15-item self-administered questionnaire related to abdominal pain, reflux, indigestion, diarrhea and constipation syndromes, that assesses the impact of gastrointestinal symptoms during the past week on a scale from 1 (no discomfort at all) to 7 (very severe discomfort).
次要结局
- Increased time in glucose range(6 weeks)
- Decreased time in hyperglycemic range(6 weeks)
- Decreased time in hypoglycemic range(6 weeks)
- Improvement in A1C(24 weeks)
- Improvement in fructosamine level(6 weeks)
研究者
Anne Peters
Professor of Medicine, Clinical Scholar
University of Southern California