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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04622722
• Other study ID #: 18.01.TH.CLI
• Status: Completed
• Phase: N/A
• Start date: August 22, 2018
• Est. completion date: May 16, 2020

Study information

• Verified date: October 2023
• Source: Société des Produits Nestlé (SPN)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 16, 2020
• Est. primary completion date: May 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• Nutren Diabetes
Nutren Diabetes provides energy at 360 kcal per 360 ml
• Isocaloric
Isocaloric diet One carton of soy milk (250 ml) and bologna sandwiches (two slices of bread) with mayonnaise

Locations

Country	Name	City	State
Thailand	Division of Nutrition & Biochemical Medicine, Department of Medicine	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Société des Produits Nestlé (SPN)	Ramathibodi Hospital

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

Gulati S, Misra A, Nanda K, Pandey RM, Garg V, Ganguly S, Cheung L. Efficacy and tolerance of a diabetes specific formula in patients with type 2 diabetes mellitus: An open label, randomized, crossover study. Diabetes Metab Syndr. 2015 Oct-Dec;9(4):252-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-hour postprandial glucose	The primary outcome will be the difference of 2-hour postprandial glucose between group A and group B	Change form baseline blood glucose level at 30,60, and 120 min.
Secondary	Area under the curve of postprandial plasma glucose (AUC glucose 0-120 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) .	Time Frame: Postprandial blood glucose response at 0, 30, 60,120 min
Secondary	Area under the curve of postprandial plasma insulin (AUC insulin 0-120 min)	The secondary outcome will be the difference of AUC insulin 0-120 min between group A and group B.	Postprandial plasma insulin response at 0, 30, 60,120 min
Secondary	Gastrointestinal tolerance	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 )	7 days prior to the treatment phase.