Pendulum D2D Glucose Control for Adults With Type 2 Diabetes

Type2 Diabetes Clinical Trial

Official title:

The Effect of Pendulum Glucose Control on GI Symptoms and Glycemic Control in Subjects With Type 2 Diabetes

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04228003
• Other study ID #: Pendulum D2D
• Status: Withdrawn
• Phase: N/A
• Start date: January 15, 2021
• Est. completion date: June 14, 2022

Study information

• Verified date: September 2021
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Gastrointestinal Symptoms
• Type2 Diabetes

Intervention

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?.

Locations

Country	Name	City	State
United States	USC Westside Center for Diabetes	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	Pendulum Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

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