Efficacy and Safety of Diabetes-specific Formula in Patients With Type 2 Diabetes Mellitus

Efficacy and Safety of Diabetes-specific Formula in Patients With Type 2 Diabetes Mellitus

Hypothesis: the diabetes-specific formula Nutren diabetes provides better postprandial glucose control in patients with type 2 diabetes when compared to the isocaloric diet.

This study is an open label, randomized controlled cross-over study

Research objectives:

1. To study the efficacy of diabetes-specific formula (Nutren Diabetes) in comparison with an isocaloric diet in the aspect of postprandial blood glucose and insulin response (baseline, 30, 60 and 120 minute).
2. To study the safety and tolerance of a diabetes-specific formula compared with an isocaloric diet in patients with type 2 diabetes mellitus

Statistical analysis method

1. Descriptive statistics: categorical data will be summarized as number and percentage, continuous data with normal distribution will be presented as means and standard deviations, and continuous data with non-normal distribution will be summarized as median, minimum and maximum.
2. Inferential statistics: Repeated Measure ANOVA from analyzing the difference of means from measuring fasting glucose and insulin more than two times.
3. Inferential statistics: Paired T-Test or Wilcoxon Matched pairs Signed Rank Test derived by analyzing the comparison between the means of two dependent groups.
4. Report of the difference between two categories by the difference of means with 95% Confidence Interval
5. Number of participant (subjects) and criteria for participation 30 participants by calculation formula of Frison and Pocock (1992) with STATA program.

Inclusion Criteria:

• DM type 2, HbA1C < 9% FPG < 180 mg/dl
• Aged between 18- 70 years.
• Participants must have stable body weight (+/- not over 5%) for the past six months.
• Participants must control their diabetes by diet control or taking diabetes medicine without medicine dose adjustment during the period of the research.
• Participants are willing to participate in the research and sign written consent form.

Exclusion Criteria:

• Participants receive insulin hormone and GPL-1 agonist injection.
• GFR < 30 ml/min/1.73 m2
• Participants have decompensated liver cirrhosis or alcoholism or drug abuse record.
• Participants have record of allergy to any ingredients in diabetes-specific formula,soybean milk or bologna and mayonnaise sandwich.
• Participants decline to participate