Type2 Diabetes Clinical Trial
Official title:
The Effect of Pendulum Glucose Control on GI Symptoms and Glycemic Control in Subjects With Type 2 Diabetes
Verified date | September 2021 |
Source | University of Southern California |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 14, 2022 |
Est. primary completion date | February 14, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Body mass index = 45 kg/m2. - 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. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | USC Westside Center for Diabetes | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of Southern California | Pendulum Therapeutics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Decreased Gastrointestinal Symptoms | 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). | 6 weeks | |
Secondary | Increased time in glucose range | Measured by continuous glucose monitor (CGM) | 6 weeks | |
Secondary | Decreased time in hyperglycemic range | Measured by continuous glucose monitor (CGM) | 6 weeks | |
Secondary | Decreased time in hypoglycemic range | Measured by continuous glucose monitor (CGM) | 6 weeks | |
Secondary | Improvement in A1C | Point of Care Hemoglobin A1c (HbA1c) % | 6 weeks | |
Secondary | Improvement in fructosamine level | Blood draw to measure fructosamine | 6 weeks | |
Secondary | Improvement in A1C | Point of Care Hemoglobin A1c (HbA1c) % | 12 weeks | |
Secondary | Improvement in A1C | Point of Care Hemoglobin A1c (HbA1c) % | 24 weeks |
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