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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
Up to 20 weight-stable subjects with type 2 diabetes
Diabetes managed by diet alone or a combination of oral agents
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 240 minutes of study
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I have type 2 diabetes and my weight has been stable.
Select...
My diabetes is controlled by diet or oral medications.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
7%
Anxiety/irritability
7%
Premature rupture of membranes
7%
Placental abnormalities
6%
Abdominal pain
5%
Pregnancy of Unknown Location
5%
Diarrhea
5%
Other complication
5%
Hospitalization-infant
5%
Mood swings
4%
Constipation
3%
Ectopic pregnancy
3%
Post-partum Infection
2%
Placenta Previa and Pre-term birth
2%
Other post-partum complication(s)
2%
Hospitalization
2%
Post-partum hemorrhage
1%
Appendicitis
1%
Pneumonia
1%
Complex cyst resulting in surgical intervention
1%
Pulmonary Embolism
1%
Flatulence
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard Lifestyle Intervention
Intensive Lifestyle Mod. Intervention

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
Hyperglycemic clamp
2017
N/A
~50
Caloric Restriction
2018
Completed Phase 3
~570

Find a Location

Who is running the clinical trial?

Adrian VellaLead Sponsor
8 Previous Clinical Trials
189 Total Patients Enrolled

Media Library

Glucagon (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05499702 — Phase 2
Type 2 Diabetes Research Study Groups: Adults with type 2 diabetes
Type 2 Diabetes Clinical Trial 2023: Glucagon Highlights & Side Effects. Trial Name: NCT05499702 — Phase 2
Glucagon (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05499702 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible to partake in this research experiment?

"To be considered for this trial, individuals must have been diagnosed with type2diabetes and aged between 25 to 65. This clinical study is hoping to recruit approximately 20 patients in total."

Answered by AI

Is enrollment in this research still ongoing?

"According to clinicaltrials.gov, the recruitment for this medical trial has been halted since August 11th 2022 after it was originally published on December 1st 2021. Despite its closure, countless other studies are currently seeking participants as of today's date."

Answered by AI

Has the Federal Drug Administration sanctioned Caloric Restriction as a valid therapy?

"Caloric Restriction received a rating of 2, signifying that the drug has some safety data but clinical trials have not yet conclusively demonstrated its efficacy."

Answered by AI

Are participants in this trial required to be under the age of 80?

"Patients aged 25 or above, but less than 65, are welcome to join this clinical trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
The Effects of Glucagon on Hepatic Metabolism in People With Type 2 Diabetes After Caloric Restriction
Adrian Vella 2022. "The Effects of Glucagon on Hepatic Metabolism in People With Type 2 Diabetes After Caloric Restriction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05499702.
~7 spots leftby Jan 2025
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