TCTR20240519007Not yet recruitingPhase 2
Clinical study of diabetes-specific formulas in patients with diabetes mellitus or prediabetes
Agricultural Research Development Agency (Public Organization)0 sites105 target enrollmentStarted: May 19, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 105
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 Years to 60 Years (—)
- Sex
- All
Inclusion Criteria
- •1.Aged between 18-60 years.
- •2.Stable weight or weight change not exceeding 5% for at least 3 months prior to joining the research, with a body weight between 70-200 kilograms.
- •3.Waist circumference exceeding standard limits: > 90 cm (36 inches) for men and > 80 cm (32 inches) for women, but not exceeding 120 cm.
- •4.Diagnosed as at risk for diabetes, defined as having a fasting plasma glucose of 100-125 mg/dL or HbA1c of 5.7-6.5%, or diagnosed with diabetes and treated with lifestyle modifications alone or in combination with metformin, with HbA1c =< 8%.
- •5.Health check-up results within the past year (if not available, the participant cannot join the study).
- •6.If taking medications such as antihypertensives, metformin, or lipid-lowering drugs, there should be no changes in medication for 3 months prior to the study, and participants must not be using insulin or other diabetes medications apart from metformin.
- •7.Willing to participate in the research by signing the consent form and strictly following the research procedures and dietary guidelines.
Exclusion Criteria
- •1.History of severe hypoglycemia with neuroglycopenia within the past 3 months.
- •2.History of severe diabetic complications such as amputation or diabetic coma.
- •3.History of impaired gastrointestinal function, such as short bowel syndrome.
- •4.Impairment in cardiac, pulmonary, or circulatory function, such as ischemic heart disease or stroke, or history of heart failure within 6 weeks prior to joining the research.
- •5.Significant abnormal laboratory results: hemoglobin < 10 g/dL, WBC < 3,000 ml (x103/uL), platelet count < 100,000 ml (x103/uL), liver enzymes (ALT, AST) > 3 times the upper limit of normal, and total bilirubin > 2 times the upper limit of normal.
- •6.Abnormal kidney function: GFR < 60 mL/min/1.73 m2 (MDRD).
- •7.Mental impairment, alcohol addiction, or substance abuse.
- •8.Symptomatic thyroid dysfunction such as hypothyroidism or hyperthyroidism.
- •9.History of cancer or presence of cancer cells within the past 5 years.
- •10.Pregnant or breastfeeding women or those refusing contraception.
- •11.Use of herbal medicines, supplements, or steroids (except topical steroids) for at least 7 consecutive days, or participation in other research projects within 4 weeks prior to this study.
- •12.Allergy to components or ingredients of the medical foods being tested.
- •13.History of lactose intolerance.
- •14.Contraindications or potential hazards from BIA (Bioelectrical Impedance Analysis), including:
- •14.1. Individuals with electrical devices or metal implants that affect body conductivity, such as pacemakers, metallic heart valves, cochlear implants, vascular clips/coils, or prostheses.
- •14.2. Individuals unable to grasp the handles for arm BIA.
- •14.3. Individuals unable to stand upright or requiring support for balance.
Investigators
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