NCT02544568

Brief Summary

Meal composition is important for blood sugar levels in patients with diabetes. The aim of this study is to investigate if a meal composition of fat, protein and carbohydrate is important for the hormonal and inflammatory responses Patients with type 1 and type 2 diabetes and healthy controls will be included in the study. At four different occasions the participants will receive lunch with the same amount of calories but different composition of fat, protein, carbohydrate and fiber. Blood samples will be taken before and after the meals. The participants will estimate their satiety. In addition participant will fill in questionnaires about their food habits and wellbeing. This study is the first study to compare both hormonal and inflammatory responses, as well as psychological aspect of the meals, after meals with different composition. Results from this study will help to make recommendation about meal composition which is beneficial for patients with diabetes type 1 and type 2.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started Nov 2009

Longer than P75 for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 9, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

March 6, 2019

Status Verified

March 1, 2019

Enrollment Period

6.3 years

First QC Date

August 26, 2015

Last Update Submit

March 4, 2019

Conditions

Diabetes Mellitus

Keywords

high fathigh proteinhigh carbohydrateinsulinglucose

Outcome Measures

Primary Outcomes (1)

  • Maximum plasma concentration [Cmax] of glucose and triglycerides

    The maximum plasma concentration of glucose and triglyceres after the meals

    1 year

Secondary Outcomes (5)

  • Maximum plasma concentration [Cmax] of IGFBP-1

    2 year

  • Maximum plasma concentration [Cmax] of marker of oxidative stress

    2 year

  • Maximum plasma concentration [Cmax] of inflammatory markers

    2 year

  • Maximum plasma concentration [Cmax] of appetite regulatory hormones

    2 years

  • Maximum plasma concentration [Cmax] of glucagon

    2 years

Study Arms (4)

High-Carb Meal

EXPERIMENTAL

The 3 Groups (Control, T1DM, T2DM) will receive 4 meals with different compositions at 4 occasions (High-Carb, High-Fat, High-Protein, High-Fibr) .

Other: Meals

High-Protein Meal

EXPERIMENTAL

The 3 Groups (Control, T1DM, T2DM) will receive 4 meals with different compositions at 4 occasions (High-Carb, High-Fat, High-Protein, High-Fibr) .

Other: Meals

High-Fat Meal

EXPERIMENTAL

The 3 Groups (Control, T1DM, T2DM) will receive 4 meals with different compositions at 4 occasions (High-Carb, High-Fat, High-Protein, High-Fibr) .

Other: Meals

High-Fibre Meal

EXPERIMENTAL

The 3 Groups (Control, T1DM, T2DM) will receive 4 meals with different compositions at 4 occasions (High-Carb, High-Fat, High-Protein, High-Fibr).

Other: Meals

Interventions

MealsOTHER

At 4 different occasions the participants will receive meals with the same amount of calories and different composition of fat, protein, carbohydrate and fiber.The composition of the meals is: Low-fat / high-carbohydrate meal (18 E% proteins, 28 E% fat and 54% carbohydrates), high-fat meal (18 E% protein, 50 E% fat and 31 E% carbohydrate), high-protein meal (40 E% protein, 30 E% fat and 30 E% carbohydrates) and low-fat / high-carbohydrate and high fiber (18 E% proteins, 28 E% fat and 54 E% carbohydrates and 15 gram of fibers).

High-Carb MealHigh-Fat MealHigh-Fibre MealHigh-Protein Meal

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with type 1 DM (age 20-75 years)
  • Patient with type 2 DM (diabetes duration more than 5 years, age 20- 75 years, BMI 26 - 33 kg/m2).
  • Healthy volunteers (age 20- 75 years).

You may not qualify if:

  • Heart failure - the New York Heart Association (NYHA) Functional Classification III-IV
  • Kidney failure - S-Creatinin mora than 200 micromol/L
  • Liver disease - Alanine aminotransferase (ALAT) more than 2 mikroKat/L

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Stockholm, 17176, Sweden

Location

MeSH Terms

Conditions

Diabetes MellitusInsulin Resistance

Interventions

Meals

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Neda R Ekberg, M.D./Ph.D.

    Karolinska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D/Ph.D

Study Record Dates

First Submitted

August 26, 2015

First Posted

September 9, 2015

Study Start

November 1, 2009

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

March 6, 2019

Record last verified: 2019-03

Locations

SE(1)