Effect of a new disease-specific enteral formula on metabolic control in type 2 diabetic patients.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21914

Enrollment

140

Registered

2006-09-12

Start date

2006-11-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus type 2 (DM type II)

Interventions

Duration intervention: 12 weeks Intervention group: diabetic specific enteral formula Control group: isocaloric standard enteral formula with fibre

Eligibility

Inclusion criteria

Inclusion criteria: 1. Type 2 diabetic patients 2. Diagnosis of type 2 diabetes according to WHO criteria for more than 6 months 3. Age >18 4. Hospitalised patients, patients in nursing homes or home-care patients 5. HbA1c between 6.1%-10,5% (including 6,1% and 10.5%) 6. 18 kg/m2 ¡Ü BMI ¡Ü 35 kg/m2 7. Indication for tube feeding for at least 6 weeks 8. Functioning GI tract, eligible for tube feeding 9. Nutrition via PEG or nasogastric tube 10. Willing to comply with the study protocol 11. Signed informed consent

Exclusion criteria

Exclusion criteria: 1. Any gastrointestinal disease that interferes with bowel function and nutritional intake (i.e. diabetes related constipation/diarrhea secondary to neuropathy, diarrhea due to chronic inflammatory bowel disease, gastroparesis, gastrectomy) 2. Concomitant intake of parenteral nutrition or other clinical enteral nutrition 3. Significant heart (NYHA class IV), hepatic (transaminase more than 3 times normal) or renal disease (requiring dialysis) 4. Concomitant therapy with acarbose 5. Concomitant therapy with systemic glucocorticoids or within 2 weeks prior to study entry 6. Nutrition via any tube that has to be placed into the jejunum 7. Galactosaemia 8. Alcohol abuse 9. Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements 10. Participation in other studies within 4 weeks of study entry

Design outcomes

Primary

Measure	Time frame
HbA1c	—

Secondary

Measure	Time frame
1. Fasting plasma glucose 2. Fasting plasma insulin 3. Fructosamine 4. Fasting plasma lipid profile: Triglycerides, Total cholesterol, LDL, HDL 5. Fasting free fatty acids (FFA) 6. Total daily insulin requirement 7. Insulin sensitivity by HOMA-IR 8. Incidence of skin, pulmonary and urinary tract infections 9. Fasting (hs) CRP 10. Fasting pro-inflammatory cytokines: IL-6, IL-8, IL-18, and TNF-¨¢ 11. Fasting plasminogen activator inhibitor-1 activity (PAI-1) 12. Blood pressure 13. Tolerance	—

Measure

Time frame

1. Fasting plasma glucose 2. Fasting plasma insulin 3. Fructosamine 4. Fasting plasma lipid profile: Triglycerides, Total cholesterol, LDL, HDL 5. Fasting free fatty acids (FFA) 6. Total daily insulin requirement 7. Insulin sensitivity by HOMA-IR 8. Incidence of skin, pulmonary and urinary tract infections 9. Fasting (hs) CRP 10. Fasting pro-inflammatory cytokines: IL-6, IL-8, IL-18, and TNF-¨¢ 11. Fasting plasminogen activator inhibitor-1 activity (PAI-1) 12. Blood pressure 13. Tolerance

—

Contacts

Public ContactM. Vries, de

Numico Research B.V. P.O. Box 75538

Miranda.deVries@numico-research.nl+31 (0)317 467800

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)