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

NCT04622722 | Completed

• 1 other identifier: 18.01.TH.CLI
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes-specific formula

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

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

  Postprandial plasma insulin response at 0, 30, 60,120 min

• Gastrointestinal tolerance

  7 days prior to the treatment phase.

Study Arms (2)

Group A

ACTIVE COMPARATOR

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

Other: Nutren Diabetes; Other: Isocaloric

Group B

PLACEBO COMPARATOR

Group B: Having Isocaloric diet provide 360 kcal.

Other: Nutren Diabetes; Other: Isocaloric

Interventions

Nutren Diabetes OTHER

Nutren Diabetes provides energy at 360 kcal per 360 ml

Group A; Group B

Isocaloric OTHER

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

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead
• Ramathibodi Hospital: collaborator

Study Sites (1)

Division of Nutrition & Biochemical Medicine, Department of Medicine

Bangkok, 10400, Thailand

Location

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

  PMID: 25458669 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Daruneewan Warodomwichit

  Division of Nutrition & Biochemical Medicine, Department of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an open-label, randomized cross-over study. The study date will be 1 day for group A and 1 day for group B, separated by 7-day wash out period. The tolerability of DSF, assessed by questionnaire, will be collected while the subjects consume DSFs daily 7 days before the study date (only group A). The questionnaire will ask about gastrointestinal symptom including abdominal distention, nausea, vomiting, and stool frequency. Group A participants will be asked to drink 360 ml of Nutren Diabetes which provides 360 kcal. Group B participants will be asked to consume isocaloric diet (360 kcal)comprising one carton of soy milk (250 ml) and bologna and mayonnaise sandwiches (two slices of bread). Plasma glucose and insulin will be collected at baseline (minute 0) and 30, 60, 120 minute postprandially. The participants will be asked to complete the questionnaire (Visual analog scale) to assess hunger and satiety at minute 0, 30, 60 and 120 minute.

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: November 10, 2020
• Study Start: August 22, 2018
• Primary Completion: May 16, 2020
• Study Completion: May 16, 2020
• Last Updated: October 3, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)