Effects on Glycemic Control of WBF-0031 in Subjects With Abnormal Glucose Tolerance

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Abnormal Glucose Tolerance

In brief

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

Key facts

Study ID

NCT04490460

Run by

Eden Miller

People needed

30

Starts

2020-06-01

Expected to finish

2021-02-28

Last updated by the study team

2020-07-29

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Between 18-80 years of age
• BMI < 45 kg/m2
• Eligible based on a recent (within the past year) blood test meeting one of these specifications:
• Fasting glucose of 100 to 125 mg/dl
• Plasma glucose measured 2 hours after a 75-gram glucose load of 140 to 199 mg/dl
• A1c of 5.7 to 6.4%
• Clinically diagnosed gestational diabetes mellitus (GDM) during a previous pregnancy (may be self-reported)
• Willing to comply with study requirements
• Provide written informed consent

You may not qualify if…

• 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.
• Active participation in another lifestyle or behavior change education or research program (DPP or weight loss program)
• Current treatment with systemic corticosteroids (topical and nasal steroids are allowed)
• Subjects who have received an antibiotic, antifungal, antiparasitic, or antiviral treatment within 30 days prior to study entry
• Pregnant women

Where it is running

• Diabetes and Obesity Care — Bend, Oregon, United States

Full record on ClinicalTrials.gov

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