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

Nestlé

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Other: Nutren Diabetes; Other: Isocaloric

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04622722

18.01.TH.CLI

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups, including a placebo group

Group A

Active Comparator group

Description:

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

Treatment:

Other: Nutren Diabetes

Other: Isocaloric

Group B

Placebo Comparator group

Description:

Group B: Having Isocaloric diet provide 360 kcal.

Treatment:

Other: Nutren Diabetes

Other: Isocaloric