What this trial means for you
This study is active, not recruiting — it is not currently taking new participants, but its results may matter for treatments you're considering. It's studying Dextrose, Clinisol 15% for healthy, type 2 diabetes, obesity.
What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.
The study, in the sponsor's words
This study is being done to better understand how amino acids alter the release of glucagon and insulin compared to glucose alone in health and disease.
Can you join? The exact criteria
Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.
Full eligibility criteria (for you and your doctor)
Inclusion Criteria - Obese Subjects with Type 2 Diabetes: * HbA1c ≤ 8.5% (type 2 diabetic subjects). * HbA1c ≤ 6.5% (obese and lean subjects). * BMI ≥ 28 Kg/M\^2 (Obese subjects with and without type 2 diabetes). * BMI ≤ 25 Kg/M\^2 (Lean subjects without type 2 diabetes). * Use of sulfonylureas or metformin only (type 2 diabetec subjects). * For female subjects: negative pregnancy test at the time of enrollment or study. * No history of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy. * No active systemic illness or malignancy. * No symptomatic macrovascular or microvascular disease. * No contraindications to MRI (e.g., metal implants, claustrophobia). * Hematocrit \> 35%. * TSH \> 0.4 or \< 5.5. * Consumption of \< 2 alcohol drinks per day or \< 14 per week or a negative AUDIT questionnaire. Exclusion Criteria - Obese Subjects with Type 2 Diabetes: * HbA1c ³ 8.5% * BMI ≤ 28 Kg/M2 * Use of insulin or agents other than sulfonylureas or metformin. * For female subjects: positive pregnancy test at the time of enrollment or study * History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy. * Active systemic illness or malignancy. * Symptomatic macrovascular or microvascular disease. * Contraindications to MRI (e.g., metal implants, claustrophobia). * Hematocrit \< 35% * TSH \< 0.4 or \> 5.5. * Consumption of \> 2 alcohol drinks per day or \> 14 per week or a positive AUDIT questionnaire. Inclusion Criteria - Obese Subjects without Type 2 Diabetes: * BMI ≥ 28 Kg/M2. * \> 5% liver fat content, as determined by MRI using the proton density fat fraction (PDFF) technique. Exclusion Criteria - Obese Subjects without Type 2 Diabetes: * HbA1c ≥ 6.5% * BMI ≤ 28 Kg/M2 * Use of any glucose-lowering agents including metformin or sulfonylureas. * For female subjects: positive pregnancy test at the time of enrollment or study * History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy. * Active systemic illness or malignancy. * Symptomatic macrovascular or microvascular disease. * Contraindications to MRI (e.g., metal implants, claustrophobia). * Hematocrit \< 35% * TSH \< 0.4 or \> 5.5. * Consumption of \> 2 alcohol drinks per day or \> 14 per week or a positive AUDIT questionnaire. Inclusion Criteria - Lean subjects without Diabetes: \- BMI ≤ 25 Kg/M\^2). Exclusion Criteria - Lean Subjects without Diabetes: * HbA1c ≥ 6.5%. * BMI ≥ 25 Kg/M\^2. * Use of any glucose-lowering agents including metformin or sulfonylureas. * For female subjects: positive pregnancy test at the time of enrollment or study. * History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy. * Active systemic illness or malignancy. * Symptomatic macrovascular or microvascular disease. * Contraindications to MRI (e.g., metal implants, claustrophobia). * Hematocrit \< 35%. * TSH \< 0.4 or \> 5.5. * Consumption of \> 2 alcohol drinks per day or \> 14 per week or a positive AUDIT questionnaire. * Liver fat content ≥ 5% as determined by MRI using the proton density fat fraction (PDFF) technique.
Study sites by state
Minnesota
- Mayo Clinic Rochester — Rochester
View the official record on ClinicalTrials.gov →
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