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

Primary Purpose

Diabetes Mellitus, Type 1

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Mixed meal with different macronutrient composition

About this trial

This is an interventional other trial for Diabetes Mellitus, Type 1 focused on measuring post-prandial glucose control, alcohol

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

Hospital Francesc de Borja

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Low Protein-Low Fat study

High Protein-High Fat study

High Protein-High Fat & alcohol study

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Plasma Glucose

Post-prandial plasma glucose time series

Secondary Outcome Measures

AUC-PG

Area Under the Curve (AUC) of Plasma Glucose in the 0-6h, 0-3h and 3-6h post-prandial periods

Full Information

NCT ID

NCT03320993

First Posted

October 20, 2017

Last Updated

March 6, 2020

Sponsor

Jorge Bondia

Collaborators

Hospital Francesc de Borja, Gandia, Spain, Ministerio de Economía y Competitividad, Spain

1. Study Identification

Unique Protocol Identification Number

NCT03320993

Brief Title

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

Official Title

Evaluación Del Impacto de la composición Nutricional de la Ingesta y Del Consumo de Alcohol en el Control glucémico Postprandial en Pacientes Con Diabetes Tipo 1

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

October 25, 2018 (Actual)

Primary Completion Date

January 23, 2020 (Actual)

Study Completion Date

January 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Jorge Bondia

Collaborators

Hospital Francesc de Borja, Gandia, Spain, Ministerio de Economía y Competitividad, Spain

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Randomized, prospective, single-centre (Hospital Francesc de Borja, Gandia, Spain), single-blind (analysis), three -way, crossover study on type 1 diabetic subjects (n=12) under intensive insulin treatment. Aim: To assess the effect of mixed meal composition on postprandial glycemic control, in subjects with type 1 diabetes: Combined effect of proteins and fats Effect of alcohol consumption Methods: Each subject will undergo three mixed meal test studies (on three different days), with identical CHO content: On one occasion a low fat-low protein meal will be given, and on another a high fat-high protein one, both consumed with a non-alcoholic drink; on a third occasion the same high fat-high protein meal will be consumed, but this time accompanied by an equal volume of an alcoholic drink. Patients will arrive at the research unit at 8:00 am and their blood glucose will be stabilized around 90 mg/dl before each mixed meal test. After the mixed meal, blood will be drawn every 5-30 min during a 6 hour post-prandial period to assess plasma glucose, hormones and metabolites concentration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 1

Keywords

post-prandial glucose control, alcohol

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

3-period, 3-treatment crossover design

Masking

Outcomes Assessor

Masking Description

Data analysis will be carried out by a person not involved in the study (she/he will be blind to the study condition)

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Low Protein-Low Fat study

Arm Type

Active Comparator

Arm Description

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

Arm Title

High Protein-High Fat study

Arm Type

Experimental

Arm Description

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

Arm Title

High Protein-High Fat & alcohol study

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Mixed meal with different macronutrient composition

Intervention Description

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

Primary Outcome Measure Information:

Title

Plasma Glucose

Description

Post-prandial plasma glucose time series

Time Frame

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

Secondary Outcome Measure Information:

Title

AUC-PG

Description

Area Under the Curve (AUC) of Plasma Glucose in the 0-6h, 0-3h and 3-6h post-prandial periods

Time Frame

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 Pre-specified Outcome Measures:

Title

Time in range

Description

Time in acceptable glucose range (70-180 mg/dl)

Time Frame

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

Title

C Max

Description

Maximum of plasma glucose concentration

Time Frame

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

Title

T max

Description

Time of Maximum plasma glucose concentration

Time Frame

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

Title

Hormones and metabolites

Description

Plasma concentration of free fatty acids, beta-OH-butyrate, lactate, alanine, counterregulatory hormones

Time Frame

6 hours (plasma hormones and metabolites will be measured every 30 minutes during the 6-hour post-prandial period)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paolo Rossetti, PhD

Organizational Affiliation

Hospital Francesc de Borja, Gandia

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jorge Bondia Company, PhD

Organizational Affiliation

Universitat Politècnica de València

Official's Role

Study Director

Facility Information:

Facility Name

Hospital Francesc de Borja

City

Gandia

State/Province

Valencia

ZIP/Postal Code

46072

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

25998293

Citation

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.

Results Reference

background

PubMed Identifier

27388474

Citation

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.

Results Reference

background

PubMed Identifier

22248115

Citation

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.

Results Reference

background

PubMed Identifier

11679452

Citation

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.

Results Reference

background

PubMed Identifier

17263767

Citation

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.

Results Reference

background

PubMed Identifier

34620620

Citation

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.

Results Reference

derived

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

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