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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: Nutren Diabetes; Other: Isocaloric

• Registration Number: NCT04622722
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief 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.

Study Timeline

• Study Start: 2018-08-22
• Study First Submitted: 2018-12-06
• Primary Completion: 2020-05-16
• Study Completion: 2020-05-16
• Study First Submitted QC: 2020-11-04
• Study First Posted: 2020-11-10
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-02
• Last Update Posted: 2023-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group B	Isocaloric	Group B: Having Isocaloric diet provide 360 kcal.
Group A	Isocaloric	Group A: Drinking Nutren Diabetes provides energy at 360 kcal per 360 ml
Group B	Nutren Diabetes	Group B: Having Isocaloric diet provide 360 kcal.
Group A	Nutren Diabetes	Group A: Drinking Nutren Diabetes provides energy at 360 kcal per 360 ml

Primary Outcome Measures

Name	Time	Method
2-hour postprandial glucose	Change form baseline blood glucose level at 30,60, and 120 min.	The primary outcome will be the difference of 2-hour postprandial glucose between group A and group B

Secondary Outcome Measures

Name	Time	Method
Area under the curve of postprandial plasma insulin (AUC insulin 0-120 min)	Postprandial plasma insulin response at 0, 30, 60,120 min	The secondary outcome will be the difference of AUC insulin 0-120 min between group A and group B.
Area under the curve of postprandial plasma glucose (AUC glucose 0-120 min)	Time Frame: Postprandial blood glucose response at 0, 30, 60,120 min	The secondary outcome will be the difference of AUC glucose 0-120 min between group A and group B.; Blood samples will be collected to assess plasma glucose at baseline and 30, 60, 120-minute postprandial. We will calculate the area under the curve of plasma glucose of patients in each arm at baseline and, 30, 60, 120 minute postprandial (AUC glucose 0-120 min) .; Blood samples will be collected to assess plasma insulin at baseline and 30, 60, 120-minute postprandial. We will calculate the area under the curve of plasma insulin of patients in each arm at baseline and, 30, 60, 120 minute postprandial (AUC insulin 0-120 min) .
Gastrointestinal tolerance	7 days prior to the treatment phase.	Gastrointestinal tolerance including abdominal distention, nausea, vomiting, and stool frequency will be assessed by questionnaire. We will collect the symptom of GI tolerance everyday during the period that the patient consumes Nutren diabetes and isocaloric diet (7 days before the study date; only participants in group A )

Trial Locations

Locations (1)

Division of Nutrition & Biochemical Medicine, Department of Medicine; 🇹🇭 Bangkok, Thailand