NCT01366794

Brief Summary

Study hypothesis is to examine the relative contribution of macronutrients for gut hormone secretion after a mixed meal in healthy volunteers and in subjects with type 2 diabetes. Individual macronutrients or a mixed meal will therefore be served and gut hormones are measured during the following 300 min.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 6, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

March 17, 2014

Status Verified

March 1, 2014

Enrollment Period

1.3 years

First QC Date

May 31, 2011

Last Update Submit

March 14, 2014

Conditions

Type 2 Diabetes

Keywords

Gut hormonesInsulin secretion

Outcome Measures

Primary Outcomes (1)

  • Release of gut hormones

    300 min

Secondary Outcomes (1)

  • Insulin secretion

    300 min

Study Arms (2)

Type 2 diabetes

EXPERIMENTAL

Administration of macronutrients in type 2 diabetes

Other: Macronutrients

Healthy volunteers

EXPERIMENTAL

Administration of macronutrients in healthy volunteers

Other: Macronutrients

Interventions

MacronutrientsOTHER

Glucose 330 kcal Protein 110 kcal Fat emulsion 110 kcal Mixed meal 550 kcal

Also known as: Glucose, Protein mixture, Fat emulsion, Mixed meal
Healthy volunteersType 2 diabetes

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy status or type 2 diabetes with dietary regulation

You may not qualify if:

  • Liver disease
  • kidney disease
  • thyroid disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Clinical Sciences Lund, Lund University

Lund, 221 84, Sweden

Location

Lund University

Lund, 22184, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

NutrientsGlucosesoybean oil, phospholipid emulsion

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesHexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Bo Ahrén, PhD

    Lund University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 31, 2011

First Posted

June 6, 2011

Study Start

September 1, 2011

Primary Completion

December 1, 2012

Study Completion

September 1, 2013

Last Updated

March 17, 2014

Record last verified: 2014-03

Locations

SE(2)