Clinical trial NCT04490460: Effects on Glycemic Control of WBF-0031 in Subjects With Abnormal Glucose Tolerance
Official title: Evaluation of the Safety and Effects on Glycemic Control of Medical Food Formulation WBF-0031 in Subjects With Abnormal Glucose Tolerance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Abnormal Glucose Tolerance
Lead sponsor: Diabetes and Obesity Care
Sponsor class: INDUSTRY
Collaborators: name: Pendulum Therapeutics
First posted: 2020-07-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Balanced randomization first arm, formulation WBF-0031 and placebo. Second arm all subjects formulation WBF-0031.
Primary purpose: TREATMENT

Brief summary: Evaluation of the safety and effects on glycemic control of medical food formulation WBF-0031 in subjects with abnormal glucose control.

Detailed description: The current study aims to investigate if altering the microbiome though Pendulum Glucose Control supplementation can have implications aimed at maintaining normal blood glucose levels that are critical for preventing diabetes and its metabolic complications. The experimental design consists of two-12 week treatment periods in subjects with prediabetes, as defined by the National Diabetes Prevention Program (DPP) criteria.

The first study period of 12 weeks will be double-blinded, placebo-controlled. The Pendulum Glucose control and placebo will be in a capsule form and identical in appearance, and dispensed to each participant according to the randomization schedule in the first 12 weeks. All subjects will receive the active product (Pendulum Glucose Control) in the second, subsequent 12 week period.

Fasting total cholesterol, triglycerides, LDL, and HDL cholesterol, Fasting insulin and Glucose, High sensitivity C Reactive Protein (hsCRP), Chemistry 14, and HbA1c will be obtained at baseline, and during first and second study period, as well as vital signs of weight, BP, and waist circumference.

In addition, CGM (Abbott System Freestyle Libre Pro) data collection will be done three times during the study as noted in Schedule of Events. Baseline Blinded CGM will be performed for approximately 14 days prior to starting the intervention with Pendulum Glucose Control. Second Blinded CGM period for approximately 14 days will occur mid-way through the intervention (weeks 5 and 6) and a third period of Blinded CGM wear will occur during the last 2 weeks of the intervention (weeks 11 and 12). During the Baseline, study period one and period 2 a mixed meal tolerance consisting of 2 Boost Shakes will be given on day 5 of each sensor wear.

At the completion of the study, analysis of the vital signs, laboratory values, CGM data for average glucose, standard deviation, TIR (time in range), as well as glycemic results of MMT for each time interval; baseline, study period one, and two.

Eligibility criteria: Inclusion Criteria:

1. Between 18-80 years of age
2. BMI \< 45 kg/m2
3. Eligible based on a recent (within the past year) blood test meeting one of these specifications:

   1. Fasting glucose of 100 to 125 mg/dl
   2. Plasma glucose measured 2 hours after a 75-gram glucose load of 140 to 199 mg/dl
   3. A1c of 5.7 to 6.4%
   4. Clinically diagnosed gestational diabetes mellitus (GDM) during a previous pregnancy (may be self-reported)
4. Willing to comply with study requirements
5. Provide written informed consent

Exclusion Criteria:

1. Known diagnosis of diabetes / taking any medication for the treatment of diabetes including the off-label use of a GLP-1 receptor agonist, SGLT-2, or metformin) within the last 3 months for weight loss.
2. Active participation in another lifestyle or behavior change education or research program (DPP or weight loss program)
3. Current treatment with systemic corticosteroids (topical and nasal steroids are allowed)
4. Subjects who have received an antibiotic, antifungal, antiparasitic, or antiviral treatment within 30 days prior to study entry
5. Pregnant women

Primary outcomes:
measure: Safety Assessment of Adverse Events
timeFrame: 30 weeks
measure: Time spent in target blood glucose
timeFrame: Three 14 day intervals
Secondary outcomes:
measure: Total Glucose Area Under the Curve (AUC) from baseline
timeFrame: 24 weeks
measure: Incremental Glucose Area Under the Curve (AUC) from baseline
timeFrame: 24 weeks
measure: Glucose peaks
timeFrame: 30 weeks
measure: A1c
timeFrame: Week 0, Week 12, Week 24
Other outcomes:
measure: Questionnaire
timeFrame: Week 0, Week 12, Week 24
Locations:
city: Bend
country: United States
facility: Diabetes and Obesity Care
state: Oregon
Study officials:
affiliation: Diabetes and Obesity Care
name: Eden Miller, D.O.
role: PRINCIPAL_INVESTIGATOR
References: