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Hormone Therapy

Caloric Restriction for Type 2 Diabetes

Phase 2

Recruiting

Research Sponsored by Adrian Vella

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diabetes managed by diet alone or a combination of oral agents

Be older than 18 years old

Must not have

Active systemic illness or malignancy

History of prior upper abdominal surgery e.g. gastric banding, pyloroplasty, vagotomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 240 minutes of study

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare whether reducing calorie intake improves the action of the hormone glucagon on metabolism of amino acids, carbohydrates and lipids in people with type 2 diabetes, in comparison to a similar trial done without reducing calorie intake.

Who is the study for?

This trial is for adults with type 2 diabetes managed by diet or oral medications, having a BMI of at least 28. Participants should be weight-stable without active illnesses, significant past surgeries, severe vascular disease, abnormal thyroid levels, contraindications to MRI scans like metal implants or claustrophobia, low hematocrit levels, or high alcohol consumption.

What is being tested?

The study examines how caloric restriction affects liver metabolism in people with type 2 diabetes. It will compare the body's response to glucagon—a hormone that raises blood sugar—before and after participants restrict their calorie intake.

What are the potential side effects?

Potential side effects are not explicitly listed but may include symptoms related to changes in diet such as fatigue, hunger discomforts and possible alterations in blood sugar levels which need careful monitoring.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My diabetes is controlled by diet or oral medications.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an active illness or another cancer.

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I have had surgery in my upper stomach area before.

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I have symptoms from large or small blood vessel problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 240 minutes of study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~240 minutes of study

This trial's timeline: 3 weeks for screening, Varies for treatment, and 240 minutes of study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of leucine oxidation in response to rising glucagon concentrations

Side effects data

From 2020 Phase 3 trial • 379 Patients • NCT02432209

29%

Admission to NICU

17%

Gestational Diabetes

13%

Nausea/vomiting

13%

Dysmenorrhea

12%

Pre-eclampsia/Eclampsia

10%

Pre-term labor

10%

Intrauterine growth restriction

10%

Back pain

Anxiety/irritability

Premature rupture of membranes

Placental abnormalities

Abdominal pain

Pregnancy of Unknown Location

Diarrhea

Other complication

Hospitalization-infant

Mood swings

Constipation

Ectopic pregnancy

Post-partum Infection

Placenta Previa and Pre-term birth

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Adults with type 2 diabetesExperimental Treatment2 Interventions

20 subjects will be studied on one occasion, following 6 weeks of caloric restriction. They will be instructed to consume a diet of 900 kcal daily using meals derived from "Nutritional Guidelines after Bariatric Surgery". Compliance will be monitored by weekly meetings with the dietician using an electronic record of food intake. After this subjects will undergo a hyperglycemic clamp with 2 doses of glucagon infused.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Caloric Restriction

2018

Completed Phase 3

~570

Hyperglycemic clamp

2017

N/A

~50