Effect of Exercise on Insulin Resistance (EFFORT)

The purpose of this study is to evaluate the effect of exercise on Insulin Resistance (IR) in subjects who do not routinely exercise and who are at risk of developing diabetes (prediabetes).

It is estimated that approximately 30-90 people will participate in this study at three study sites in the United States and United Kingdom.

Study Overview

• Status: Terminated
• Conditions: Prediabetic State
• Intervention / Treatment: Behavioral: Intensive Exercise Group; Behavioral: Current Recommendations Exercise Group

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M23 9QZ
    • Manchester University
  • Newcastle upon Tyne, United Kingdom, NE1 7RU
    • Move Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

1. Aged 18 to 75 years.

2. Meets one of the three diagnostic criteria listed below (based on screening results or recorded result within one week of enrollment);

   1. Fasting plasma or whole blood glucose (fasting defined as no caloric intake for at least 8 hours): 100 ≤ 125 mg/dL (6.0-6.9 mmol/L)
   2. HbA1c of 5.7% - 6.4% (39 - 46 mmol/mol)
   3. 2-hour plasma glucose of 140-199 mg/dL (7.8-11.0 mmol/L) during an OGTT (as described by the WHO using a glucose load of 75 g anhydrous glucose dissolved in water)
3. No clinically significant adverse exercise response during the maximal graded exercise test

Exclusion Criteria

1. Weight loss diet program or weight change (>10%) within the past 6 months
2. Daily physical activity of >10,000 steps per day (as measured during the interval between visits 1 and 2)
3. Participates in deliberate structured exercise
4. Pregnant or intending to become pregnant
5. Cognitive or intellectual disability that prevents subject from providing informed consent or following protocol instructions.
6. Unwillingness to participate in all study procedures
7. Inability to give blood through multiple venous phlebotomies or to have an intravenous catheter
8. BMI greater than 40 kg/m2
9. Concurrent participation in another lifestyle modification trial

10. Diagnosis of diabetes based on any one of the following criteria:

    1. Fasting plasma or whole blood glucose ≥ 126 mg/dL (7 mmol/L)
    2. HbA1c of >6.5% (>47 mmol/mol)
    3. 2-hour plasma glucose ≥ 200 mg/dL (11.1 mmol/L) during an OGTT

11. Any pre-existing or newly discovered medical condition that is deemed likely to put the subject at risk of injury during this trial. This may include but is not limited to:

    1. Clinically relevant vascular or cerebrovascular event (e.g. stroke, recurrent transient ischemic attack (TIA), deep venous thrombosis or intracardiac thrombi, clinically significant edema within the previous 6 months
    2. Current use of anti-psychotic, anti-convulsant, anti-coagulant, sedative medication, or cognition-enhancing medications
    3. Current use of beta blockers (beta-adrenergic blocking agents)
    4. Current or previous use (within the past year) of the following medications: diabetes related medications or insulin; metformin; growth hormone; glucagon; dipeptidyl peptidase-4(DPP-4) inhibitors (saxagliptin, stigagliptin); glucagon-Like Peptide-1(GLP-1) mimetics (exenatide, liraglutide); sulfonylurea medication or other potential confounding medications
    5. Medical conditon which predetermines insulin resistance (e.g. Marfan syndrome / severe Polycystic ovary syndrome (PCOS) / Cushing syndrome etc.).
    6. Fasting triglycerides > 1000 mg/dL.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intensive Exercise Group; Behavioral	Behavioral: Intensive Exercise Group
Experimental: Current Recommendations Exercise Group; Behavioral	Behavioral: Current Recommendations Exercise Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
A decrease in Insulin Resistance (IR) as measured by a change in IR.	change between baseline and 6 weeks

Collaborators and Investigators

• Sponsor: Alere San Diego
• Investigators: Study Director: Rick San George, PhD, Alere San Diego; Principal Investigator: Michael Trenell, PhD, Newcastle University

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: September 6, 2013
• First Submitted That Met QC Criteria: September 10, 2013
• First Posted (Estimated): September 13, 2013

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 29, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hyperinsulinism; Prediabetic State; Insulin Resistance
• Other Study ID Numbers: BSTE-0902