Clinical study of diabetes-specific formulas in patients with diabetes mellitus or prediabetes

Phase 2

• Conditions: type 2 diabetesprediabetes; type 2 diabetes; prediabetes; medical food

• Registration Number: TCTR20240519007
• Lead Sponsor: Agricultural Research Development Agency (Public Organization)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-19
• Last Update Posted: 19 August 2024
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 105

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HbA1C Baseline and day91 Blood test

Secondary Outcome Measures

Name	Time	Method
Fasting plasma glucose Baseline, day30, and day91 Blood test,Lipid profile Baseline and day91 Blood test,Body weight Baseline, day14, day30, day60, day91 Scale,Waist circumference Baseline, day14, day30, day60, day91 Measuring tape