Pendulum D2D Glucose Control for Adults With Type 2 Diabetes

Not Applicable

Withdrawn

• Conditions: Type2 Diabetes; Gastrointestinal Symptoms
• Interventions: Dietary Supplement: Pendulum Glucose Control formulation for T2D

• Registration Number: NCT04228003
• Lead Sponsor: University of Southern California

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.

Study Timeline

• Study First Submitted: 2020-01-10
• Study First Submitted QC: 2020-01-10
• Study First Posted: 2020-01-14
• Study Start: 2021-01-15
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-29
• Last Update Posted: 2021-10-07
• Primary Completion: 2022-02-14
• Study Completion: 2022-06-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pendulum	Pendulum Glucose Control formulation for T2D	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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	24 weeks	Point of Care Hemoglobin A1c (HbA1c) %
Improvement in fructosamine level	6 weeks	Blood draw to measure fructosamine

Trial Locations

Locations (1)

USC Westside Center for Diabetes; 🇺🇸 Los Angeles, California, United States