NCT01593215

Brief Summary

The investigators have recently discovered a genetic variant in an adrenergic receptor that leads to increased risk for type 2 diabetes. The investigators have also seen that blockers of that receptor improves impaired insulin secretion in animals. The investigators will now test the blocker in patients with type 2 diabetes with or without the risk variant in an effort to make diabetes treatment more individualized.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2 type-2-diabetes

Timeline
Completed

Started May 2012

Typical duration for phase_2 type-2-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

May 1, 2012

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 8, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
3 months until next milestone

Results Posted

Study results publicly available

January 9, 2015

Completed
Last Updated

January 9, 2015

Status Verified

January 1, 2015

Enrollment Period

2.4 years

First QC Date

May 3, 2012

Results QC Date

October 31, 2014

Last Update Submit

January 7, 2015

Conditions

Type 2 Diabetes

Keywords

geneticstype 2 diabetesinsulin secretion

Outcome Measures

Primary Outcomes (1)

  • Insulin Secretion

    insulin secretion will be measured (nMole) in response to an oral glucose tolerance test. Patients will receive the capsules 1 h before the glucose test, and the insulin levels 30 minutes after the oral glucose will be used as a primary outcome measure. The insulin levels at the highest tolerated dose of yohimbine will be used.

    30 minutes after oral glucose

Secondary Outcomes (1)

  • Glucose

    30 minutes after oral glucose

Study Arms (2)

Placebo first then yohimbine

ACTIVE COMPARATOR

placebo first, then yohimbine

Drug: Yohimbine

Yohimbine first then placebo

ACTIVE COMPARATOR

Yohimbine first then placebo

Drug: Yohimbine

Interventions

YohimbineDRUG

Yohimbine capsule

Placebo first then yohimbineYohimbine first then placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • type 2 diabetes
  • informed consent
  • age 18-70, for females only postmenopausal

You may not qualify if:

  • heart disease
  • anxiety disorder
  • antidiabetic treatment other than metformin
  • adrenergic blockers
  • ulcus
  • allergy to any component in the capsules

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skanes Universitetssjukhus

Malmo, Skåne County, 20502, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Yohimbine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Secologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Results Point of Contact

Title
Anders Rosengren
Organization
RegionSkane
anders.rosengren@med.lu.se
+4640391169

Study Officials

  • Anders Rosengren, MD PhD

    Region Skane

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

May 3, 2012

First Posted

May 8, 2012

Study Start

May 1, 2012

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

January 9, 2015

Results First Posted

January 9, 2015

Record last verified: 2015-01

Locations

SE(1)