Efficacy and Safety of Diabetes-specific Formula in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

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

Detailed description: 
      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.
    

Intervention name(s): Nutren Diabetes; Isocaloric
Intervention type(s): Other; Other
Intervention description(s): Nutren Diabetes provides energy at 360 kcal per 360 ml; Isocaloric diet One carton of soy milk (250 ml) and bologna sandwiches (two slices of bread) with mayonnaise
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is an open-label, randomized cross-over study.
The study date will be 1 day for group A and 1 day for group B, separated by 7-day wash out period.
The tolerability of DSF, assessed by questionnaire, will be collected while the subjects consume DSFs daily 7 days before the study date (only group A). The questionnaire will ask about gastrointestinal symptom including abdominal distention, nausea, vomiting, and stool frequency.
Group A participants will be asked to drink 360 ml of Nutren Diabetes which provides 360 kcal.
Group B participants will be asked to consume isocaloric diet (360 kcal)comprising one carton of soy milk (250 ml) and bologna and mayonnaise sandwiches (two slices of bread).
Plasma glucose and insulin will be collected at baseline (minute 0) and 30, 60, 120 minute postprandially. The participants will be asked to complete the questionnaire (Visual analog scale) to assess hunger and satiety at minute 0, 30, 60 and 120 minute.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes-specific formula