Gastrointestinal Symptoms, Type2 Diabetes
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTPendulum Glucose Control formulation for T2D
All bacteria contained in the study product formulation are commensal organisms that have been repeatedly documented to inhabit the human GI tract under normal circumstances. Pendulum's Glucose Control Formulation consists of five human commensal microbial strains including butyrate producing and mucin-degrading strains. The organisms were grown under controlled conditions consistent with Good Manufacturing Practices (GMP) and employ no animal-derived products. All ingredients utilized during manufacturing were food grade and qualified as generally recognized as safe (GRAS). The product is provided as acid-resistant capsules in bottles that are to be stored refrigerated at 4℃.
Sponsors
Pendulum Therapeutics
University of Southern California
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study is a single site, prospective, open label, observational, single arm trial in 30 patients with type 2 diabetes with gastrointestinal complaints.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decreased Gastrointestinal Symptoms | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Increased time in glucose range | 6 weeks | Measured by continuous glucose monitor (CGM) |
| Decreased time in hyperglycemic range | 6 weeks | Measured by continuous glucose monitor (CGM) |
| Decreased time in hypoglycemic range | 6 weeks | Measured by continuous glucose monitor (CGM) |
| Improvement in A1C | 6 weeks | Point of Care Hemoglobin A1c (HbA1c) % |
| Improvement in fructosamine level | 6 weeks | Blood draw to measure fructosamine |
Countries
United States
Outcome results
None listed