Diabetes Mellitus
Conditions
Keywords
Enteral nutrition, dietary fiber, sodium intake, blood pressure, glycemic status, long-term care, tube feeding
Brief summary
This study aims to evaluate the effects of a fiber-enriched, sodium-controlled enteral nutrition formula on glycemia, blood pressure, and nutritional status in long-term care residents with diabetes receiving tube feeding. Participants receive the enteral formula as their sole source of nutrition for 3 months, followed by a 1-month post-intervention follow-up period. Clinical outcomes including metabolic parameters, blood pressure, and safety indicators are assessed.
Detailed description
This prospective single-arm interventional study was conducted in long-term care residents with diabetes receiving tube feeding. The study protocol was approved by the Institutional Review Board of Taipei Medical University (TMU-IRB-201504036). Participants received a standardized enteral nutrition formula enriched with dietary fiber and designed with controlled sodium content, providing approximately 1500 kcal/day as the sole nutritional source. The intervention lasted for 3 months, followed by a 1-month observation period. Clinical assessments were conducted at baseline (M0), post-intervention (M1), and follow-up (M2). Outcomes included glycemic parameters (blood glucose, HbA1c), blood pressure, nutritional biomarkers (albumin, total protein), lipid profile, liver and kidney function, hematological indices, electrolyte levels, and gastrointestinal tolerance. This study aims to explore whether targeted nutritional composition, including fiber enrichment and sodium control, can contribute to maintaining metabolic and cardiovascular stability in tube-fed residents with diabetes.
Interventions
DIETARY_SUPPLEMENTFiber-Enriched, Sodium-Controlled Enteral Formula
A standardized enteral nutrition formula enriched with dietary fiber and formulated with controlled sodium content, providing approximately 1500 kcal/day.
Sponsors
Taipei Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 20-85 years * Diagnosed with diabetes mellitus (HbA1c ≥ 6%) * Receiving tube feeding for at least 3 months * Clinically stable condition
Exclusion criteria
* Terminal cancer * Liver cirrhosis * Severe renal failure or uremia * Lactose intolerance * Any condition deemed unsuitable by investigators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic and diastolic blood pressure | baseline, 3 months, and 4 months | Blood pressure will be measured in millimeters of mercury (mmHg), including systolic and diastolic blood pressure. Lower values indicate better blood pressure control. Participants will be assessed at baseline, after the 3-month intervention period, and at 4 months during follow-up. |
| Fasting blood glucose | Baseline, 3 months, and 4 months | Fasting blood glucose will be measured in mg/dL, with lower values indicating better glycemic control. Participants will be assessed at baseline, after the 3-month intervention period, and at 4 months during follow-up. |
| Glycated hemoglobin (HbA1c) | Baseline, 3 months, and 4 months | Glycated hemoglobin (HbA1c) will be measured as a percentage (%), with lower values indicating better glycemic control. |
| Serum albumin | Baseline, 3 months, and 4 months | Serum albumin will be measured in grams per deciliter (g/dL), with higher values indicating better nutritional status. |
| Serum total protein | Baseline, 3 months, and 4 months | Serum total protein will be measured in grams per deciliter (g/dL), with higher values indicating better nutritional status. |
| Total cholesterol | Baseline, 3 months, and 4 months | Total cholesterol will be measured in milligrams per deciliter (mg/dL), with lower values indicating a better lipid profile. |
| Triglycerides | Baseline, 3 months, and 4 months | Triglycerides will be measured in milligrams per deciliter (mg/dL), with lower values indicating a better lipid profile. |
| High-density lipoprotein cholesterol (HDL-C) | Baseline, 3 months, and 4 months | High-density lipoprotein cholesterol (HDL-C) will be measured in milligrams per deciliter (mg/dL), with higher values indicating a better lipid profile. |
| Low-density lipoprotein cholesterol (LDL-C) | Baseline, 3 months, and 4 months | Low-density lipoprotein cholesterol (LDL-C) will be measured in milligrams per deciliter (mg/dL), with lower values indicating a better lipid profile. |
| Geriatric Nutritional Risk Index (GNRI) | Baseline, 3 months, and 4 months | The Geriatric Nutritional Risk Index (GNRI) is calculated using serum albumin and body weight relative to ideal body weight. Lower GNRI values indicate a higher risk of malnutrition. |
| Subjective Global Assessment (SGA) | Baseline, 3 months, and 4 months | The Subjective Global Assessment (SGA) is a clinical tool used to assess nutritional status, classifying patients into categories (A: well-nourished, B: moderately malnourished, C: severely malnourished). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aspartate aminotransferase (AST) | Baseline, 3 months, and 4 months | Aspartate aminotransferase (AST) will be measured in units per liter (U/L), with lower values indicating better liver function. |
| Alanine aminotransferase (ALT) | Baseline, 3 months, and 4 months | Alanine aminotransferase (ALT) will be measured in units per liter (U/L), with lower values indicating better liver function. |
| Blood urea nitrogen (BUN) | Baseline, 3 months, and 4 months | Blood urea nitrogen (BUN) will be measured in milligrams per deciliter (mg/dL), with lower values indicating better kidney function. |
| Serum creatinine | Baseline, 3 months, and 4 months | Serum creatinine will be measured in milligrams per deciliter (mg/dL), with lower values indicating better kidney function. |
| Gamma-glutamyl transferase (GGT) | Baseline, 3 months, and 4 months | Gamma-glutamyl transferase (GGT) will be measured in units per liter (U/L), with lower values indicating better liver function. |
| Total bilirubin | Baseline, 3 months, and 4 months | Total bilirubin will be measured in milligrams per deciliter (mg/dL), with lower values indicating better liver function. |
| Lactate dehydrogenase (LDH) | Baseline, 3 months, and 4 months | Lactate dehydrogenase (LDH) will be measured in units per liter (U/L), with values reflecting tissue injury. |
| Creatine phosphokinase (CPK) | Baseline, 3 months, and 4 months | Creatine phosphokinase (CPK) will be measured in units per liter (U/L), with higher values indicating muscle damage. |
| Serum sodium | Baseline, 3 months, and 4 months | Serum sodium will be measured in millimoles per liter (mmol/L). |
| Serum potassium | Baseline, 3 months, and 4 months | Serum potassium will be measured in millimoles per liter (mmol/L). |
| Serum chloride | Baseline, 3 months, and 4 months | Serum chloride will be measured in millimoles per liter (mmol/L). |
| Serum calcium | Baseline, 3 months, and 4 months | Serum calcium will be measured in milligrams per deciliter (mg/dL). |
| Serum phosphorus | Baseline, 3 months, and 4 months | Serum phosphorus will be measured in milligrams per deciliter (mg/dL). |
| Serum magnesium | Baseline, 3 months, and 4 months | Serum magnesium will be measured in milligrams per deciliter (mg/dL). |
| Complete blood count (CBC) | Baseline, 3 months, and 4 months | Complete blood count (CBC) will be performed using standard laboratory methods, including white blood cell count (WBC), red blood cell count (RBC), hemoglobin (HGB), hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), and platelet count (PLT). Parameters will be reported in standard clinical units. |
| Urinary urea nitrogen (UUN) | Baseline, 3 months, and 4 months | Urinary urea nitrogen (UUN) will be measured in grams per day (g/day) or milligrams per deciliter (mg/dL), reflecting protein metabolism and nitrogen balance. |
| Urinary sodium | Baseline, 3 months, and 4 months | Urinary sodium will be measured in millimoles per liter (mmol/L), reflecting sodium balance and intake. |
| Urine osmolality | Baseline, 3 months, and 4 months | Urine osmolality will be measured in milliosmoles per kilogram (mOsm/kg), reflecting urine concentration. |
| Urinalysis | Baseline, 3 months, and 4 months | Urinalysis will be performed using standard laboratory methods, including specific gravity, pH, color, and clarity (clear or turbid), to assess general urinary characteristics. |
| Bowel movement frequency | Baseline, 3 months, and 4 months | Gastrointestinal tolerance will be assessed by bowel movement frequency, defined as the number of bowel movements per day. |
Countries
Taiwan
Outcome results
None listed