Fat Metabolites and Gut Hormones

NCT ID: NCT03223389

Last Updated: 2017-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-07

Study Completion Date

2018-12-31

Brief Summary

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To investigate the effects of different fat metabolites on gut hormone secretion in gastric bypass operated subjects and BMI-matched controls.

Detailed Description

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Dietary triglycerides are hydrolyzed during digestion to two fatty acids and one 2-monoacyl glycerol. The study will investigate the effects of these different fat components on gut hormone secretion in gastric bypass operated patients and non-operated BMI-matched controls.

Conditions

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Overweight and Obesity Type 2 Diabetes Bariatric Surgery Gut Hormones Dietary Fat

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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10 gastric bypass operated patients

3 different oils ingested at separate study days will be tested against each others ability to induce gut hormone secretion.

Group Type EXPERIMENTAL

C-8 dietary oil

Intervention Type DIETARY_SUPPLEMENT

Ingestion of 13.15 g C-8 dietary oil providing 0.0216 mol of triglycerides.

Tricaprylin

Intervention Type DIETARY_SUPPLEMENT

Ingestion of 10.17 g tricaprylin providing 0.0216 mol of triglycerides.

Olive oil

Intervention Type DIETARY_SUPPLEMENT

Ingestion of 19 g olive oil providing 0.0216 mol of triglycerides.

10 healthy control subjects

3 different oils ingested at separate study days will be tested against each others ability to induce gut hormone secretion.

Group Type EXPERIMENTAL

C-8 dietary oil

Intervention Type DIETARY_SUPPLEMENT

Ingestion of 13.15 g C-8 dietary oil providing 0.0216 mol of triglycerides.

Tricaprylin

Intervention Type DIETARY_SUPPLEMENT

Ingestion of 10.17 g tricaprylin providing 0.0216 mol of triglycerides.

Olive oil

Intervention Type DIETARY_SUPPLEMENT

Ingestion of 19 g olive oil providing 0.0216 mol of triglycerides.

Interventions

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C-8 dietary oil

Ingestion of 13.15 g C-8 dietary oil providing 0.0216 mol of triglycerides.

Intervention Type DIETARY_SUPPLEMENT

Tricaprylin

Ingestion of 10.17 g tricaprylin providing 0.0216 mol of triglycerides.

Intervention Type DIETARY_SUPPLEMENT

Olive oil

Ingestion of 19 g olive oil providing 0.0216 mol of triglycerides.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Uncomplicated gastric bypass surgery performed minimum 12 months prior to study

Exclusion Criteria

* Type 1 or 2 diabetes mellitus prior to or after gastric bypass surgery
* Pregnancy or breastfeeding
* Haemoglobin levels below 6,5 mM
* Gall bladder removal

Healthy control subjects:


* Bariatric surgery or complicated upper abdominal surgery
* Gall bladder removal
* Pregnancy or breastfeeding
* Haemoglobin levels below 6,5 mM
* Co-morbidities or medicine significantly affecting glucose metabolism or appetite regulation
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Copenhagen

OTHER

Sponsor Role collaborator

Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Christoffer Martinussen

Medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dept. of Endocrinology

Hvidovre, , Denmark

Site Status

Countries

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Denmark

Central Contacts

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Sten Madsbad, Professor

Role: CONTACT

+4538623032

Facility Contacts

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Christoffer Martinussen, MD

Role: primary

+4538623032

References

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Martinussen C, Dirksen C, Bojsen-Moller KN, Svane MS, Carlsson ER, Hartmann B, Clausen TR, Veedfald S, Kristiansen VB, Rehfeld JF, Hansen HS, Holst JJ, Madsbad S. Intestinal sensing and handling of dietary lipids in gastric bypass-operated patients and matched controls. Am J Clin Nutr. 2020 Jan 1;111(1):28-41. doi: 10.1093/ajcn/nqz272.

Reference Type DERIVED
PMID: 31742316 (View on PubMed)

Other Identifiers

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CM-FAT-17

Identifier Type: -

Identifier Source: org_study_id

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