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New treatment option for PreDiabetes
Official title To Evaluate the Impact of Consumption of a Bioactive Compound on Fasting Blood Glucose Levels in Asian Indians With Pre-diabetes
ClinicalTrials.gov ID: NCT06417840
What this study is testing
- What it's testing
- This is randomized placebo controlled, double-blinded, parallel arm study on free living Asian Indians. Eligible subjects will undergo one-week run-in period and subjects will be asked to maintain their usual diet and exercise regime.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50. Healthy volunteers may be eligible.
You may be able to join if
- Fasting Blood Glucose between 100-125 mg/dL;
- and BMI range 25-30 kg/m2;
- and waist circumference ≥80cm for women and ≥90cm for men;
You likely can't join if
- Weight loss or gain ≥4.5 kg within 90 days of visit 1.
- Use of weight loss medications within 90 days of visit 1.
- History of gastrointestinal surgery (e.g., bariatric surgery) or cosmetic procedures (e.g., liposuction) for weight/fat reducing purposes.
- Use of dietary supplements or related products that, in the judgment of the Investigator, are likely to markedly affect weight loss or appetite...
- History of extreme dietary habits (e.g., Atkins diet, etc.), as judged by the Investigator.
- History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional.
See the full eligibility criteria
- Fasting Blood Glucose between 100-125 mg/dL;
- and BMI range 25-30 kg/m2;
- and waist circumference ≥80cm for women and ≥90cm for men;
- Weight loss or gain ≥4.5 kg within 90 days of visit 1.
- Use of weight loss medications within 90 days of visit 1.
- History of gastrointestinal surgery (e.g., bariatric surgery) or cosmetic procedures (e.g., liposuction) for weight/fat reducing purposes.
- Use of dietary supplements or related products that, in the judgment of the Investigator, are likely to markedly affect weight loss or appetite within 30 days of visit 1.
- History of extreme dietary habits (e.g., Atkins diet, etc.), as judged by the Investigator.
- History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional.
- Current medical diagnosis of type 1 or type 2 diabetes mellitus.
- HbA1c ≥48 mmol/mol (6.5%) as measured at visit 1.
- History of a chronic gastrointestinal disorder, such as peptic ulcer disease or malabsorption syndrome (mild lactose intolerance or gastroesophageal reflux diseases are acceptable).
- Signs or symptoms of an active infection of clinical relevance within 5 days of visit 1. The visit may be rescheduled such that all signs and symptoms have resolved (at the discretion of the Clinical Investigator) at...
- Is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period...
- Any condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put the...
- Excessive alcohol consumption (\> 2 Drinks, 60 ml of Whisky Per Day).
The study team makes the final eligibility decision.
Where it's taking place
- New Delhi, India
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, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Delhi, India. 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.