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Randomized Study of Yohimbine Treatment for Type 2 Diabetes Patients Carrying a Specific Genetic Risk Variant (YOH1)

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Region Skane
Lund University
Information provided by (Responsible Party):
Anders Rosengren, MD PhD, Region Skane
ClinicalTrials.gov Identifier:
NCT01593215
First received: May 3, 2012
Last updated: August 21, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
 Drug: Yohimbine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Study of Yohimbine Treatment for Type 2 Diabetes Patients Carrying a Specific Genetic Risk Variant

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Region Skane:

Primary Outcome Measures:
  • Insulin secretion [ Time Frame: 30 minutes after oral glucose ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • glucose [ Time Frame: 30 minutes after oral glucose ] [ Designated as safety issue: No ]
    Plasma glucose will be measure (mMole) in response to an oral glucose tolerance test. Patients will receive the capsules 1 h before the glucose test, and the glucose levels 30 minutes after the oral glucose will be used as a secondary outcome measure. The glucose levels at the highest tolerated dose of yohimbine will be used.


Estimated Enrollment: 300
Study Start Date: May 2012
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
placebo
 Drug: Yohimbine
Yohimbine capsule
Active Comparator: Yohimbine
Yohimbine
 Drug: Yohimbine
Yohimbine capsule

Detailed Description:

We have recently discovered a genetic variant in an adrenergic receptor that leads to increased risk for type 2 diabetes. We have also seen that blockers of that receptor improves impaired insulin secretion in animals. We 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. Patients will receive two different acute doses of the blocker and the effect will be measured with oral glucose tolerance tests. Then the effect of the blocker will be tested during a one-week treatment period. The study is a randomized placebo-controlled study.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • heart disease
  • anxiety disorder
  • antidiabetic treatment other than metformin
  • adrenergic blockers
  • ulcus
  • allergy to any component in the capsules
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01593215

Locations
Sweden
Skanes Universitetssjukhus
Malmo, Skane, Sweden, 20502
Sponsors and Collaborators
Anders Rosengren, MD PhD
Region Skane
Lund University
Investigators
Principal Investigator: Anders Rosengren, MD PhD Region Skane
  More Information

No publications provided

Responsible Party: Anders Rosengren, MD PhD, MD PhD, Region Skane
ClinicalTrials.gov Identifier: NCT01593215     History of Changes
Other Study ID Numbers: 2010-018604-85
Study First Received: May 3, 2012
Last Updated: August 21, 2012
Health Authority: Sweden: Medical Products Agency

Keywords provided by Region Skane:
genetics
type 2 diabetes
insulin secretion

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Yohimbine
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
 Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013