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

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: Nutren Diabetes; Other: Isocaloric

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Division of Nutrition & Biochemical Medicine, Department of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; Group A: Drinking Nutren Diabetes provides energy at 360 kcal per 360 ml	Other: Nutren Diabetes; Nutren Diabetes provides energy at 360 kcal per 360 ml; Other: Isocaloric; Isocaloric diet One carton of soy milk (250 ml) and bologna sandwiches (two slices of bread) with mayonnaise
Placebo Comparator: Group B; Group B: Having Isocaloric diet provide 360 kcal.	Other: Nutren Diabetes; Nutren Diabetes provides energy at 360 kcal per 360 ml; Other: Isocaloric; Isocaloric diet One carton of soy milk (250 ml) and bologna sandwiches (two slices of bread) with mayonnaise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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.

Collaborators and Investigators

• Sponsor: Société des Produits Nestlé (SPN)
• Collaborators: Ramathibodi Hospital
• Investigators: Principal Investigator: Daruneewan Warodomwichit, Division of Nutrition & Biochemical Medicine, Department of Medicine

Publications and helpful links

General Publications

• 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. doi: 10.1016/j.dsx.2014.10.001. Epub 2014 Nov 1.

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2018
• Primary Completion (Actual): May 16, 2020
• Study Completion (Actual): May 16, 2020

Study Registration Dates

• First Submitted: December 6, 2018
• First Submitted That Met QC Criteria: November 4, 2020
• First Posted (Actual): November 10, 2020

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Diabetes-specific formula
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 18.01.TH.CLI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No