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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-22

Study Completion Date

2020-05-16

Brief Summary

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

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Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

Group A: Drinking Nutren Diabetes provides energy at 360 kcal per 360 ml

Group Type ACTIVE_COMPARATOR

Nutren Diabetes

Intervention Type OTHER

Nutren Diabetes provides energy at 360 kcal per 360 ml

Isocaloric

Intervention Type OTHER

Isocaloric diet One carton of soy milk (250 ml) and bologna sandwiches (two slices of bread) with mayonnaise

Group B

Group B: Having Isocaloric diet provide 360 kcal.

Group Type PLACEBO_COMPARATOR

Nutren Diabetes

Intervention Type OTHER

Nutren Diabetes provides energy at 360 kcal per 360 ml

Isocaloric

Intervention Type OTHER

Isocaloric diet One carton of soy milk (250 ml) and bologna sandwiches (two slices of bread) with mayonnaise

Interventions

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Nutren Diabetes

Nutren Diabetes provides energy at 360 kcal per 360 ml

Intervention Type OTHER

Isocaloric

Isocaloric diet One carton of soy milk (250 ml) and bologna sandwiches (two slices of bread) with mayonnaise

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No