Metformin and Muscle in Insulin-resistant Older Veterans

NCT01804049 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: CLIN-019-12S
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Sarcopenia is the loss of muscle mass, strength and function with aging and is associated with increased disability, falls and fractures. Older adults with diabetes and prediabetes are insulin resistant and have a higher risk of developing sarcopenia. This study examines the use of metformin, an antidiabetic drug, for preventing the development of sarcopenia in older adults with prediabetes.

Conditions

Prediabetes

Keywords

metformin; muscle; insulin resistance; sarcopenia; older adults; impaired fasting glucose

Outcome Measures

Primary Outcomes (1)

• Change in Total Lean Mass From Baseline

  At baseline, 1, 2, and 3 year follow-up visits, participants will have whole body dual x-ray absorptiometry scans (DXA) with a Hologic QDR 4500W DXA scanner by a certified DXA operator to determine total body lean mass and appendicular lean mass (Kg). The changes in appendicular and total lean mass were calculated by determining the change from baseline to the three year data point. If participants withdrew from the study prior to collection of 3 year data, the final time point available was used.

  3 years

Secondary Outcomes (2)

• Change in Physical Performance - 400 Meter Walk Speed

  3 years

• Change in Muscle Characteristics

  6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

60 participants will be randomized to placebo pills.

Drug: placebo

Metformin

ACTIVE COMPARATOR

60 enrolled participants will be randomized to metformin.

Drug: metformin

Interventions

metformin DRUG

Metformin will be given at a dose of 850 mg orally once daily for 1 month with titration up to 850 mg orally twice daily for the remainder of the study.

Also known as: Glucophage

Metformin

placebo DRUG

One placebo capsule by mouth once daily for 1 month followed by one placebo capsule by mouth twice daily for the remainder of the study.

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• The investigators will enroll 120 sedentary, weight-stable, ambulatory Veterans aged 65 years and older with prediabetes identified with fasting glucose values 100 mg/dL or greater but under 126 mg/dL with no use of diabetes medications.
• Participants must demonstrate that they are able to ambulate 400 meters without assistance.

You may not qualify if:

• Chronic medical conditions affecting muscle mass or function like active non-skin cancer and hypogonadism
• Medications affecting muscle mass or function like glucocorticoids and androgen/antiandrogens
• Contraindications to metformin such as renal dysfunction defined as creatinine \>= 1.5 mg/dL for men or \>=1.4 mg/dL for women or estimated glomerular filtration rate (eGFR)\<60 mL/min; liver dysfunction defined as alanine aminotransferase (ALT)\>48 U/L, aspart aminotransferase (AST)\>41 U/L or alkaline phosphatase (AlkPhos)\>141 U/L; B12 deficiency defined as B12 level \<180 pg/dL; congestive heart failure; known hypersensitivity to metformin; excessive alcohol intake (average of 2 or more alcoholic beverages/day over a month)
• Conditions that include bleeding risk such as the use of warfarin, clopidogrel/ticlopidine, aggrenox, dabigatran or anagrelide; laboratory results showing platelets\<150 billion/L or international normalized ratio (INR)\>1.2 or activated partial thromboplastin time (aPTT)\>36 seconds
• Allergy to lidocaine

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Oregon Health and Science University: collaborator

Study Sites (1)

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Prediabetic State; Insulin Resistance; Sarcopenia

Interventions

Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Dr Robert Klein
• Organization: VAORD - Portland VA Health Care System

kleinro@ohsu.edu

503-220-8268

Study Officials

• Robert F Klein

  VA Portland Health Care System, Portland, OR

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2013
• First Posted: March 5, 2013
• Study Start: April 8, 2014
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: February 11, 2020
• Results First Posted: February 11, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)