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Completed

NCT Number: NCT04622722

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Nutrition & Biochemical Medicine, Department of Medicine

Bangkok, 10400, Thailand

About this study

This study is an open label, randomized controlled cross-over study

Research objectives:

  • 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).
  • 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

  • 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.
  • Inferential statistics: Repeated Measure ANOVA from analyzing the difference of means from measuring fasting glucose and insulin more than two times.
  • Inferential statistics: Paired T-Test or Wilcoxon Matched pairs Signed Rank Test derived by analyzing the comparison between the means of two dependent groups.
  • Report of the difference between two categories by the difference of means with 95% Confidence Interval
  • Number of participant (subjects) and criteria for participation 30 participants by calculation formula of Frison and Pocock (1992) with STATA program.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nutren Diabetes

Other

Nutren Diabetes provides energy at 360 kcal per 360 ml

Isocaloric

Other

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

Primary outcomes

  1. 2-hour postprandial glucose

    Time frame: 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 outcomes

  1. Area under the curve of postprandial plasma glucose (AUC glucose 0-120 min)

    Time frame: 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) .

  2. Area under the curve of postprandial plasma insulin (AUC insulin 0-120 min)

    Time frame: 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.

  3. Gastrointestinal tolerance

    Time frame: 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 )

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Collaborators

  • Ramathibodi Hospital

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Nov 10, 2020
Registry last updated
Oct 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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