Clinical trial NCT04228003: Pendulum D2D Glucose Control for Adults With Type 2 Diabetes
Official title: The Effect of Pendulum Glucose Control on GI Symptoms and Glycemic Control in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Type2 Diabetes
Gastrointestinal Symptoms
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Pendulum Therapeutics
First posted: 2020-01-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Decreased Gastrointestinal Symptoms
timeFrame: 6 weeks
Secondary outcomes:
measure: Increased time in glucose range
timeFrame: 6 weeks
measure: Decreased time in hyperglycemic range
timeFrame: 6 weeks
measure: Decreased time in hypoglycemic range
timeFrame: 6 weeks
measure: Improvement in A1C
timeFrame: 6 weeks
measure: Improvement in fructosamine level
timeFrame: 6 weeks
measure: Improvement in A1C
timeFrame: 12 weeks
measure: Improvement in A1C
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Westside Center for Diabetes
state: California
Study officials:
affiliation: University of Southern California
name: Anne L Peters, MD
role: PRINCIPAL_INVESTIGATOR
References: