An interventional study of Pendulum Glucose Control formulation for T2D in Type2 Diabetes and Gastrointestinal Symptoms, sponsored by University of Southern California. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-07.
Sponsored by University of Southern California · Not applicable, Interventional, and Treatment
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.
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.
University of Southern California is the lead sponsor of 789 studies on the registry; 136 are open to participants now.
Of its 69 completed or terminated interventional studies of FDA-regulated products, 32 (46%) have results posted.
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Exclusion Criteria:
Pendulum Glucose Control formulation for T2D will be taken twice daily - 1 capsule with the morning meal and 1 capsule with the evening meal for 8 weeks with an option of continuing up to 6 months.
Dietary Supplement: Pendulum 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℃.
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).
Time frame: 6 weeks
Increased time in glucose range
Measured by continuous glucose monitor (CGM)
Time frame: 6 weeks
Decreased time in hyperglycemic range
Measured by continuous glucose monitor (CGM)
Time frame: 6 weeks
Decreased time in hypoglycemic range
Measured by continuous glucose monitor (CGM)
Time frame: 6 weeks
Improvement in A1C
Point of Care Hemoglobin A1c (HbA1c) %
Time frame: 6 weeks
Improvement in fructosamine level
Blood draw to measure fructosamine
Time frame: 6 weeks
Improvement in A1C
Point of Care Hemoglobin A1c (HbA1c) %
Time frame: 12 weeks
Improvement in A1C
Point of Care Hemoglobin A1c (HbA1c) %
Time frame: 24 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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