Clinical Nursing Protocols for Insulin Resistance Research

CLEAR Study Objectives

The study is trying to determine why skeletal muscle becomes insulin resistant in obesity.

Researchers compare three groups:

  1. Lean insulin-sensitive
  2. Obese insulin-sensitive
  3. Obese insulin-resistant

The key study procedures are:

  • ✅ OGTT
  • ✅ DEXA
  • ✅ VO2 Max
  • ✅ Hyperinsulinemic-Euglycemic Clamp
  • ✅ Muscle Biopsies
  • ✅ Blood/urine collection

The clamp and biopsies are the most important nurse-related procedures.

Essential Nursing Knowledge

Screening Eligibility Criteria

Know these key criteria:

Included

  • Age 30-65
  • Sedentary
  • Non-smoker
  • Stable weight
  • BP ≤ 150/95

Excluded

  • Type 1 or Type 2 diabetes
  • Pregnancy
  • Active smoking, nicotine, or THC use
  • GLP-1 medications (Ozempic, Wegovy, Trulicity, etc.)
  • Metformin
  • Steroids
  • Blood thinners
  • Significant cardiac disease [POINTS 2.0 Protocol]

OGTT and Group Assignment

2-Hour Glucose:

140-199 mg/dL = Insulin Resistant

This is very important because it determines whether a participant belongs in Group B or Group C. [POINTS 2.0 Protocol], [POINTS Summary Sheet]

Visit 1 Clinical Procedures

Typical nursing involvement includes:

NIRS Test

  • Cuff inflation to 220 mmHg
  • Monitor participant comfort

DEXA

  • Verify pregnancy testing is complete, if applicable

VO2 Max

  • Ensure ECG monitoring
  • Watch for symptoms:
    • Chest pain
    • Dizziness
    • Arrhythmias
    • Shortness of breath

Activity Monitor

  • Educate the participant
  • Ensure wear instructions are given

The Hyperinsulinemic-Euglycemic Clamp Visit

Night Before

Participant:

  • Admitted overnight
  • Receives a standardized dinner
  • Begins fasting

Nurse responsibilities:

  • ✅ Review medications
  • ✅ Verify fasting status
  • ✅ Collect urine
  • ✅ Pregnancy test if needed
  • ✅ Prepare for morning clamp

Clamp Setup and IV Access

Requirements:

Two IVs Minimum

IV #1:

  • Insulin
  • Glucose
  • Tracer infusion

IV #2:

  • Blood sampling

Monitor access carefully because frequent blood draws occur throughout the study.

Clamp Procedure Timeline

Baseline

Tracer starts first.

After 2 Hours

Insulin infusion begins at 40 mU/m²/min.

Goal

Maintain glucose at 🎯 ~90 mg/dL (using D20 adjustments).

Monitoring

Fingersticks/NOVA performed every 5-10 minutes.

Monitoring for Hypoglycemia

This is the most important safety concern. Watch for:

  • Sweating
  • Tremors
  • Palpitations
  • Hunger
  • Anxiety
  • Dizziness
  • Change in mental status

If glucose is falling:

  • ✅ Increase D20
  • ✅ Increase monitoring frequency
  • ✅ Notify provider

A study physician/provider is available during the procedure.

Muscle Biopsy Procedures

The study uses the Vastus lateralis.

Biopsies occur at:

  • ✅ Baseline
  • ✅ Post-clamp
  • ✅ Optional 30-minute biopsy

Nursing responsibilities:

  • Assist the provider
  • Maintain a sterile field
  • Monitor for bleeding
  • Reinforce dressing
  • Assess pain
  • Monitor for post-procedure complications

Common complications include:

  • Bruising
  • Hematoma
  • Bleeding
  • Infection

Respiratory Hood and Metabolic Monitoring

Performed twice during the clamp. Purpose:

  • Measure fat oxidation
  • Measure carbohydrate utilization

Nurse Pearl: Participants sometimes feel claustrophobic, hot, or anxious. Provide reassurance and monitor tolerance.

Specimen Collection and Priorities

This study is extremely specimen-driven. Specimens include:

  • ✅ Blood
  • ✅ Urine
  • ✅ Muscle tissue

The muscle tissue is the entire reason for the study. Always verify:

  • Correct participant ID
  • Correct labeling
  • Appropriate processing pathway
  • Timely transport

Adverse Events and Safety Monitoring

Clamp

  • Hypoglycemia
  • IV infiltration
  • Vasovagal events

Biopsy

  • Bleeding
  • Infection
  • Hematoma

VO2 Max

  • Arrhythmias
  • Chest pain
  • Syncope

Venipuncture

  • Hematoma
  • Infection

Post-Procedure Follow-Up Visit

Within 24-72 hours after biopsy, assess for:

  • ✅ Pain
  • ✅ Bleeding
  • ✅ Drainage
  • ✅ Infection
  • ✅ Bruising
  • ✅ Any AE/SAE

This visit can be virtual.

POINTS: Nursing Memory Sheet

P: Pregnancy test before DEXA or clamp

O: OGTT determines group

I: Insulin clamp at ~90 mg/dL

N: Need two IVs

T: Tissue biopsies are critical

S: Safety = watch for hypoglycemia & biopsy complications

Summary of your role: Your primary responsibilities are participant safety during the hyperinsulinemic-euglycemic clamp, support of muscle biopsy procedures, specimen integrity, and monitoring for hypoglycemia, bleeding, and procedure-related adverse events.