Impact of Meal Composition and Alcohol Consumption on Postprandial Glycemic Control in Subjects With Type 1 Diabetes

NCT03320993 | Completed

• 1 other identifier: DPI2016-78831-C2-1-R_alcohol
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Postprandial glucose control is a challenging issue in everyday diabetes care. Indeed, excessive postprandial glucose excursions are the major contributors to plasma glucose (PG) variability in subjects with type 1 diabetes (T1DM). In addition, the poor reproducibility of postprandial glucose response is burdensome for patients and healthcare professionals. To date, the majority of prandial insulin dosing algorithms for subjects with T1DM considers only the carbohydrate (CHO) content of the meal. However, there is evidence (although with a certain degree of heterogeneity) that meal composition significantly affects postprandial glucose control, contributing to glycemic variability. Moreover, despite the high prevalence of alcohol consumption among patients with T1DM (about 30%, similar to that of the general population), data regarding its effect on the postprandial period are very limited. This project will evaluate the effect of meal composition and alcohol consumption on postprandial glucose control in subjects with T1DM under intensive insulin treatment.

Conditions

Diabetes Mellitus, Type 1

Keywords

post-prandial glucose control; alcohol

Outcome Measures

Primary Outcomes (1)

• Plasma Glucose

  Post-prandial plasma glucose time series

  6 hours (plasma glucose will be measured every 5-15 minutes during the 6-hour post-prandial period of each mixed meal test).

Secondary Outcomes (1)

• AUC-PG

  AUC of plasma glucose will be calculated for the whole 6 hour post-prandial period, for the early 0-3 hour post-prandial period and for the late 3-6 hour post-prandial period.

Other Outcomes (4)

• Time in range

  6 hours (time in range during the 6 hour post-prandial period)

• C Max

  6 hours (maximum plasma glucose concentration during the 6 hour post-prandial period)

• T max

  6 hours (Time of maximum plasma glucose concentration during the 6 hour post-prandial period)

Study Arms (3)

Low Protein-Low Fat study

ACTIVE COMPARATOR

Subjects will receive a mixed meal with carbohydrates (70g) plus a low content of proteins and fats

Other: Mixed meal with different macronutrient composition

High Protein-High Fat study

EXPERIMENTAL

Subjects will receive a mixed meal with the same carbohydrates content of arm 1 (70g), but a greater amount of fats and proteins

Other: Mixed meal with different macronutrient composition

High Protein-High Fat & alcohol study

EXPERIMENTAL

Subjects will receive the same mixed meal of the High Protein-High Fat study plus 0,7g of alcohol per Kg of weight

Other: Mixed meal with different macronutrient composition

Interventions

Mixed meal with different macronutrient composition OTHER

A mixed meal with identical amount of carbohydrates but different content of protein, fat and alcohol will be given

High Protein-High Fat & alcohol study; High Protein-High Fat study; Low Protein-Low Fat study

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with type 1 diabetes mellitus for more than one year, aged between 18 and 60 years; on intensive insulin therapy by means of CSII (continuous subcutaneous insulin infusion) or MDI (multiple daily injections) for at least 6 months before screening; glycosylated haemoglobin of 6-8.5%; without severe chronic micro- and macroangiopathic diabetic complications and with a body mass index (BMI) between 18 and 30 kg/m2.

You may not qualify if:

• Pregnancy and lactation
• Hypoglycemia unawareness
• Fatal or progressive disease
• Drugs or alcohol abuse
• HIV, active hepatitis B, active hepatitis C
• Hepatic disease (aminotransferases AST or ALT \>2 times above normal)
• Clinically relevant microangiopathic disease, or other diseases that may interfere with participation in the study or data analysis
• Pre-planned surgery
• Blood donation in the previous 3 months for men and 6 months for women
• Mental conditions that may interfere with the subject's comprehension of the aims and possible consequences of the study
• Non-compliant subjects
• Use of experimental medications or devices during the previous 30 days

Sponsors & Collaborators

• Jorge Bondia: lead
• Hospital Francesc de Borja, Gandia, Spain: collaborator
• Ministerio de Economía y Competitividad, Spain: collaborator

Study Sites (1)

Hospital Francesc de Borja

Gandia, Valencia, 46072, Spain

Location

Related Publications (6)

• Bell KJ, Smart CE, Steil GM, Brand-Miller JC, King B, Wolpert HA. Impact of fat, protein, and glycemic index on postprandial glucose control in type 1 diabetes: implications for intensive diabetes management in the continuous glucose monitoring era. Diabetes Care. 2015 Jun;38(6):1008-15. doi: 10.2337/dc15-0100.

  PMID: 25998293 BACKGROUND

• Bell KJ, Toschi E, Steil GM, Wolpert HA. Optimized Mealtime Insulin Dosing for Fat and Protein in Type 1 Diabetes: Application of a Model-Based Approach to Derive Insulin Doses for Open-Loop Diabetes Management. Diabetes Care. 2016 Sep;39(9):1631-4. doi: 10.2337/dc15-2855. Epub 2016 Jul 7.

  PMID: 27388474 BACKGROUND

• Barnard K, Sinclair JM, Lawton J, Young AJ, Holt RI. Alcohol-associated risks for young adults with Type 1 diabetes: a narrative review. Diabet Med. 2012 Apr;29(4):434-40. doi: 10.1111/j.1464-5491.2012.03579.x.

  PMID: 22248115 BACKGROUND

• Turner BC, Jenkins E, Kerr D, Sherwin RS, Cavan DA. The effect of evening alcohol consumption on next-morning glucose control in type 1 diabetes. Diabetes Care. 2001 Nov;24(11):1888-93. doi: 10.2337/diacare.24.11.1888.

  PMID: 11679452 BACKGROUND

• Kerr D, Cheyne E, Thomas P, Sherwin R. Influence of acute alcohol ingestion on the hormonal responses to modest hypoglycaemia in patients with Type 1 diabetes. Diabet Med. 2007 Mar;24(3):312-6. doi: 10.1111/j.1464-5491.2006.02054.x.

  PMID: 17263767 BACKGROUND

• Garcia A, Moscardo V, Ramos-Prol A, Diaz J, Boronat M, Bondia J, Rossetti P. Effect of meal composition and alcohol consumption on postprandial glucose concentration in subjects with type 1 diabetes: a randomized crossover trial. BMJ Open Diabetes Res Care. 2021 Oct;9(1):e002399. doi: 10.1136/bmjdrc-2021-002399.

  PMID: 34620620 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Study Officials

• Paolo Rossetti, PhD

  Hospital Francesc de Borja, Gandia

  PRINCIPAL INVESTIGATOR

• Jorge Bondia Company, PhD

  Universitat Politècnica de València

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data analysis will be carried out by a person not involved in the study (she/he will be blind to the study condition)
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: 3-period, 3-treatment crossover design

Study Record Dates

• First Submitted: October 20, 2017
• First Posted: October 25, 2017
• Study Start: October 25, 2018
• Primary Completion: January 23, 2020
• Study Completion: January 31, 2020
• Last Updated: March 9, 2020

Record last verified: 2020-03

Locations

ES (1)