NCT03261362

Brief Summary

The purpose of this study is to clarify the role of the branched-chain amino acids in the development of Insulin resistance in patients with diabetes

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable diabetes

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

March 1, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

June 5, 2023

Status Verified

June 1, 2023

Enrollment Period

3.8 years

First QC Date

August 22, 2017

Last Update Submit

June 2, 2023

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • Clamp test

    Insulin sensitivity test

    up to 24 weeks

Secondary Outcomes (1)

  • Mixed Meal Test

    up to 24 weeks

Study Arms (2)

Amino acid powder with all amino acids

PLACEBO COMPARATOR

amino acid powder 80 g oral Administration 1 week

Dietary Supplement: Branched-chain amino acids reduced intake

Amino acid powder without BCAAs-reduced intake

ACTIVE COMPARATOR

Branched-chain amino acids reduced intake - amino acid powder lacking BCAAs 80 g oral Administration 1 week -

Dietary Supplement: Branched-chain amino acids reduced intake

Interventions

Branched-chain amino acids reduced intakeDIETARY_SUPPLEMENT
Amino acid powder with all amino acidsAmino acid powder without BCAAs-reduced intake

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diabetes type 2
  • Non smokers
  • Untrained
  • Willingness to adhere to a diet intervention

You may not qualify if:

  • Chronic disease
  • Pregnancy
  • Cancer
  • Antibiotic therapy
  • Drug/alcohol abuse
  • Competitive athletes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

German Diabetes Centre

Düsseldorf, 40225, Germany

Location

Related Publications (1)

  • Karusheva Y, Koessler T, Strassburger K, Markgraf D, Mastrototaro L, Jelenik T, Simon MC, Pesta D, Zaharia OP, Bodis K, Barenz F, Schmoll D, Wolkersdorfer M, Tura A, Pacini G, Burkart V, Mussig K, Szendroedi J, Roden M. Short-term dietary reduction of branched-chain amino acids reduces meal-induced insulin secretion and modifies microbiome composition in type 2 diabetes: a randomized controlled crossover trial. Am J Clin Nutr. 2019 Nov 1;110(5):1098-1107. doi: 10.1093/ajcn/nqz191.

    PMID: 31667519DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Michael Roden, MD

    Deutsches Diabetes Zentrum

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2017

First Posted

August 25, 2017

Study Start

March 1, 2016

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

June 5, 2023

Record last verified: 2023-06

Locations

DE(1)