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New treatment option for Prediabetes
Official title Effects of Dihydroberberine (DHB) on GLP-1, Glycemic Control, Appetite, and Mood in Adults With Pre-Diabetes
ClinicalTrials.gov ID: NCT07210684
What this study is testing
- What it's testing
- The goal of this clinical trial is to learn if Dihydroberberine (DHB) supplementation affects adults with pre-diabetes. The main questions it aims to answer are: Does DHB supplementation increase the concentration of GLP-1 in the blood?
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 35 to 65
You may be able to join if
- 1.35 - 65 years of age (inclusive). 2.BMI 25.0 - 35.0 kg/m2 (inclusive). 3.HbA1c 5.7% - 6.4% (39 - 47 mmol/mol, inclusive) measured at visit 1...
- 5.Non-user or former user (daily use; cessation ≥12 months) of tobacco or nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) within...
- 6.Non-habitual users (i.e., daily or almost daily) of marijuana or hemp products, including CBD/THC products, and willing to abstain from use...
- 7.Willing to wear a CGM sensor throughout study period and willing to adhere to instructions/ restrictions associated with the proper use and care of...
- 8.Willing to use personal smart phone with operating system capable of downloading and operating the Cronometer and Dexcom CGM apps for diet records...
You likely can't join if
- Extreme Diets: Extreme dietary habits (e.g., ketogenic, vegan/vegetarian) at investigator's discretion.
- Intense Exercise: Moderate-to-intense physical training (≥5 hours/week).
- Weight Instability/Program: Recent weight changes (\>4.5 kg≤90 d) or current/planned weight change program.
- Abnormal Labs: Abnormal lab test results of clinical significance at Visit 1 (one re-test allowed).
- Uncontrolled Chronic Illness: Uncontrolled or clinically important pulmonary, cardiac, hepatic, renal, endocrine (T1D/T2D excluded), hematologic...
- Clinically Important GI: Clinically important GI condition interfering with study product (e.g., IBD, celiac, weight loss surgery history).
See the full eligibility criteria
Who can join
- 1.35 - 65 years of age (inclusive). 2.BMI 25.0 - 35.0 kg/m2 (inclusive). 3.HbA1c 5.7% - 6.4% (39 - 47 mmol/mol, inclusive) measured at visit 1. 4.Participant has a score of 7 - 10 on the Vein Access Scale Assessment at...
- 5.Non-user or former user (daily use; cessation ≥12 months) of tobacco or nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) within 12 months of visit 1, and has no plans to begin use during the study...
- 6.Non-habitual users (i.e., daily or almost daily) of marijuana or hemp products, including CBD/THC products, and willing to abstain from use throughout the study period (topical creams/lotions are allowed).
- 7.Willing to wear a CGM sensor throughout study period and willing to adhere to instructions/ restrictions associated with the proper use and care of the CGM.
- 8.Willing to use personal smart phone with operating system capable of downloading and operating the Cronometer and Dexcom CGM apps for diet records and blood glucose, respectively.
- 9.Willing to adhere to all study procedures, including lifestyle considerations, and sign forms providing informed consent to participate in the study and authorization to release relevant protected health information...
What rules you out
- Extreme Diets: Extreme dietary habits (e.g., ketogenic, vegan/vegetarian) at investigator's discretion.
- Intense Exercise: Moderate-to-intense physical training (≥5 hours/week).
- Weight Instability/Program: Recent weight changes (\>4.5 kg≤90 d) or current/planned weight change program.
- Abnormal Labs: Abnormal lab test results of clinical significance at Visit 1 (one re-test allowed).
- Uncontrolled Chronic Illness: Uncontrolled or clinically important pulmonary, cardiac, hepatic, renal, endocrine (T1D/T2D excluded), hematologic, immunologic, neurologic, psychiatric, or biliary disorders.
- Clinically Important GI: Clinically important GI condition interfering with study product (e.g., IBD, celiac, weight loss surgery history).
- Uncontrolled HTN: Uncontrolled hypertension (SBP≥160 mmHg and/or DBP≥100 mmHg).
- Cancer History: History or presence of cancer in the prior 2 years (except non-melanoma skin cancer).
- Active Infection: Signs/symptoms of active infection ≤5 d of Visit 1.
- Anti-Hyperglycemics: Recent use (≤6 mo) of any prescription anti-hyperglycemic medication.
- Other Supplements: Use of dietary supplements (other than approved multivitamin) ≤14 d of Visit 1.
- Alcohol/Substance Abuse: History (≤12 months) of alcohol (\>14 drinks/week) or substance abuse.
- Antibiotics: Antibiotic use ≤90 d of Visit 1.
- Regular NSAIDs: Regular use (≥3 days/week≤30 d) of anti-inflammatory medications.
- Steroid Use: Recent use (≤30 d) of oral/injectable steroids, or high-dose topical/inhaled steroids.
- Unregistered Drug: Exposure to any non-registered drug product ≤30 d prior to Visit 1
- Medication Instability: Unstable dose (≤90 d) of any other prescription medications (PRN excluded).
- Psychiatric Hospitalization: Major affective/psychiatric disorder requiring hospitalization ≤12 months prior to Visit 1.
- Recent Trauma/Surgery: Major trauma or any surgical event ≤30 d of Visit 1.
- Recent GI Prep: Endoscopy or colonoscopy preparation ≤90 d prior to Visit 1.
- Planned Surgery: Scheduled or planning elective surgical procedures during the study.
- Female Status: Pregnancy, lactation, planning pregnancy, or unwillingness to use approved contraception.
- Allergies: Known sensitivity or allergy to any study products or foods.
- Investigator Discretion: Any condition that interferes with compliance, confounds results, or presents undue risk.
The study team makes the final eligibility decision.
Where it's taking place
- Addison, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 35 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Addison, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.